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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K951623
Device Name TLC SURGICAL GOWNS
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 Number878.4040
Classification Product Code
FYA  
Date Received04/07/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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