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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 K963188
Device Name DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
Applicant
Codi International BV
3903 Lv Veenendaal
Turbinestraat 13-19,  NL
Applicant Contact C. VAN ZWETSELAAR
Correspondent
Codi International BV
3903 Lv Veenendaal
Turbinestraat 13-19,  NL
Correspondent Contact C. VAN ZWETSELAAR
Classification Product Code
EFQ  
Date Received08/15/1996
Decision Date 10/30/1996
Decision Substantially Equivalent (SESE)
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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