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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 K933159
Device Name XYZ PADS
Applicant
Aso Corp.
300 Sarasota Center Blvd.
Sarasota,  FL  34240
Applicant Contact JOAN RUBENDALL
Correspondent
Aso Corp.
300 Sarasota Center Blvd.
Sarasota,  FL  34240
Correspondent Contact JOAN RUBENDALL
Classification Product Code
EFQ  
Date Received06/29/1993
Decision Date 12/13/1993
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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