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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K954314
Device Name ULTRAFIT LINERS
Applicant
Stahmer Weston Scientific
170 W. Rd.
Portsmouth,  NH  03801
Applicant Contact FRED WESTON
Correspondent
Stahmer Weston Scientific
170 W. Rd.
Portsmouth,  NH  03801
Correspondent Contact FRED WESTON
Regulation Number878.4040
Classification Product Code
LYU  
Date Received09/15/1995
Decision Date 12/28/1995
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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