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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 K954243
Device Name TECNOL SALINE WET 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
FRO  
Date Received09/11/1995
Decision Date 11/29/1995
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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