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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K880309
Device Name TYPE 316L STAINLESS STEEL WIRE
Applicant
Winn Hirsch & Assoc.
5256 NW 15th St.
Margate,  FL  33063
Applicant Contact WINN HIRSCH
Correspondent
Winn Hirsch & Assoc.
5256 NW 15th St.
Margate,  FL  33063
Correspondent Contact WINN HIRSCH
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received01/25/1988
Decision Date 02/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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