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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 K922055
Device Name STERILE AND NON-STERILE GAUZE SPONGES
Applicant
Team Mfg., Inc.
P.O. Box 15427
Augusta,  GA  30919
Applicant Contact NORRIS R HAROD
Correspondent
Team Mfg., Inc.
P.O. Box 15427
Augusta,  GA  30919
Correspondent Contact NORRIS R HAROD
Classification Product Code
EFQ  
Date Received05/04/1992
Decision Date 08/10/1992
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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