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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K903486
Device Name MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493
Applicant
Pennsylvania Association For the Blind
Washington-Green County Branch
566 E. Maiden St.
Washington,  PA  15301
Applicant Contact DENNIS R CHARLTON
Correspondent
Pennsylvania Association For the Blind
Washington-Green County Branch
566 E. Maiden St.
Washington,  PA  15301
Correspondent Contact DENNIS R CHARLTON
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/31/1990
Decision Date 10/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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