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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 K896176
Device Name EXUSORB(TM) DRY/WET DRESSING
Applicant
CONTROLLED THERAPEUTICS CORP.
ONE TECHNOLOGY COURT
MALVERN,  PA  19355
Applicant Contact CRAIG E HAMMES
Correspondent
CONTROLLED THERAPEUTICS CORP.
ONE TECHNOLOGY COURT
MALVERN,  PA  19355
Correspondent Contact CRAIG E HAMMES
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received10/25/1989
Decision Date 11/24/1989
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
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