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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K972225
Device Name UFR FIBEROPTIC CABLE
Applicant
Universal Fiberoptic Repair, Inc.
9 Wrights Crossing
Pomfret Center,  CT  06259
Applicant Contact DEREK N MAY
Correspondent
Universal Fiberoptic Repair, Inc.
9 Wrights Crossing
Pomfret Center,  CT  06259
Correspondent Contact DEREK N MAY
Regulation Number878.4580
Classification Product Code
FST  
Date Received06/13/1997
Decision Date 03/18/1998
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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