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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, Internal
510(k) Number K941099
Device Name CLEAN-SORB
Applicant
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Applicant Contact JOHN QUIGLEY
Correspondent
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Correspondent Contact JOHN QUIGLEY
Classification Product Code
EFQ  
Date Received03/07/1994
Decision Date 09/30/1994
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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