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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K812711
Device Name STERILE GAUZE PADS 12PLY
Applicant
Medspec Corp.
65 E. Palatime #209
Prospect Heights,  IL  60070
Applicant Contact Jacob Bomberg
Correspondent
Medspec Corp.
65 E. Palatime #209
Prospect Heights,  IL  60070
Correspondent Contact Jacob Bomberg
Regulation Number878.4014
Classification Product Code
NAB  
Date Received09/24/1981
Decision Date 11/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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