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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 K121134
Device Name TL TRISEB CREAM
Applicant
Trigen Laboratories, Inc.
11705 Boyette Rd., Suite 171
Riverview,  FL  33569
Applicant Contact MELISSA GOODHEAD
Correspondent
Trigen Laboratories, Inc.
11705 Boyette Rd., Suite 171
Riverview,  FL  33569
Correspondent Contact MELISSA GOODHEAD
Classification Product Code
FRO  
Date Received04/13/2012
Decision Date 07/25/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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