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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K904604
Device Name REDI-RELEASE ABSORBENT DRESSING
Applicant
Fountain Pharmaceuticals, Inc.
11201 Concept Blvd.
Suite A
Largo,  FL  34643
Applicant Contact W FOUNTAIN
Correspondent
Fountain Pharmaceuticals, Inc.
11201 Concept Blvd.
Suite A
Largo,  FL  34643
Correspondent Contact W FOUNTAIN
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received10/10/1990
Decision Date 01/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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