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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K894274
Device Name EXUSORB TRANSPARENT DRESSING
Applicant
CONTROLLED THERAPEUTICS CORP.
ONE TECHNOLOGY COURT
MALVERN,  PA  19355
Applicant Contact CRAIG HAMMES
Correspondent
CONTROLLED THERAPEUTICS CORP.
ONE TECHNOLOGY COURT
MALVERN,  PA  19355
Correspondent Contact CRAIG HAMMES
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/22/1989
Decision Date 08/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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