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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K971472
Device Name SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
Applicant
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Applicant Contact NORBERT D THOMPSON
Correspondent
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Correspondent Contact NORBERT D THOMPSON
Regulation Number878.3300
Classification Product Code
FTL  
Date Received04/23/1997
Decision Date 07/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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