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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K895606
Device Name EXUSORB(TM) GEL DRESSING
Applicant
Controlled Therapeutics Corp.
One Technology Ct.
Malvern,  PA  19355
Applicant Contact CRAIG E HAMMES
Correspondent
Controlled Therapeutics Corp.
One Technology Ct.
Malvern,  PA  19355
Correspondent Contact CRAIG E HAMMES
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/18/1989
Decision Date 10/19/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
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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