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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Surgical
510(k) Number K954556
Device Name SURGICAL CAP
Applicant
Thai Disposable Products Co., Ltd.
Sukhumvit Rd. (Soi 117)
Bang Muang Mai, Muang District
Samutprakaran,  TH 10270
Applicant Contact THAWATCHAI MATURAPORN
Correspondent
Thai Disposable Products Co., Ltd.
Sukhumvit Rd. (Soi 117)
Bang Muang Mai, Muang District
Samutprakaran,  TH 10270
Correspondent Contact THAWATCHAI MATURAPORN
Regulation Number878.4040
Classification Product Code
FYF  
Date Received10/02/1995
Decision Date 03/12/1996
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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