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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
510(k) Number K951474
Device Name TLC SURGICAL DRAPES
Applicant
Tlc Tech Lab Clothes, Inc.
2875 Leon St.
Muskegon,  MI  49441
Applicant Contact DAWN ERICKSON-STEVENS
Correspondent
Tlc Tech Lab Clothes, Inc.
2875 Leon St.
Muskegon,  MI  49441
Correspondent Contact DAWN ERICKSON-STEVENS
Regulation Number878.3500
Classification Product Code
KKY  
Date Received03/30/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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