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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K955575
Device Name TECNOL HYDROGEL WOUND DRESSING
Applicant
Tecnol Medical Products, Inc.
6316 Airport Fwy.
Fort Worth,  TX  76117
Applicant Contact PAM LIBERTO
Correspondent
Tecnol Medical Products, Inc.
6316 Airport Fwy.
Fort Worth,  TX  76117
Correspondent Contact PAM LIBERTO
Classification Product Code
MGQ  
Date Received12/07/1995
Decision Date 01/17/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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