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fda 510k en14683 surgical ear loop masks

Surgical Masks - Premarket Notification [510(k ...

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Guidance on Surgical Masks - Premarket Notification [510(k ...

Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004.

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(Mask, Surgical) - FDA 510(k) Applications Database

223 rows · FDA 510(k) Number: Applicant: Device Name: Decision Date: K910182: 3M COMPANY: …

FDA 510(K) NUMBERAPPLICANTDEVICE NAMEDECISION DATEK9101823M COMPANY3M BRAND EAR LOOP FACE MASK, 20…03/04/1991K9553823M COMPANY3M MODEL 1860 HEALTH CARE PARTI…05/01/1996K9407073M COMPANY3M SURGICAL MASK WITH FACE SHEILD05/23/1994K8816183M COMPANYASEPTEX 1809 FLUID-RESISTANT MOL…05/09/1988See all 223 rows on 510k.medevnet

510(k) Premarket Notification

Search FDA . Home; Food; Drugs; Medical Devices; Radiation-Emitting Products; ... mask, surgical: 510(k) Number: K160269: Device Name: Surgical Face Masks (Ear loops and Tie-on) Applicant: SAN-M PACKAGE CO., LTD. 1086-1 Ojiro: shimada-city, JP 428-8652 Applicant Contact: shogo nagao ...

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510(k) Premarket Notification

Device Classification Name: mask, surgical: 510(k) Number: K023755: Device Name: WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK …

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3M™ Ear Loop Face Mask 2000F, 50/box | 3M United States

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