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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 K955513
Device Name SURGICAL MASK (NON-STERILE)
Applicant
United Medical Ent., Inc.
5003 Wrightsboro Rd.
Grovetown,  GA  30813
Applicant Contact HERSCHEL PITTS
Correspondent
United Medical Ent., Inc.
5003 Wrightsboro Rd.
Grovetown,  GA  30813
Correspondent Contact HERSCHEL PITTS
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/04/1995
Decision Date 04/22/1996
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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