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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K894996
Device Name EXUSORB(TM) GRANULES
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
Classification Product Code
FRO  
Date Received08/08/1989
Decision Date 09/28/1989
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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