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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Surgical
510(k) Number K864375
Device Name TYPE 316L COTTER WIRE
Applicant
Winn Hirsch & Assoc.
30 Sylvia Rd.
Plainview,  NY  11803
Applicant Contact WIN HIRSCH
Correspondent
Winn Hirsch & Assoc.
30 Sylvia Rd.
Plainview,  NY  11803
Correspondent Contact WIN HIRSCH
Regulation Number888.3030
Classification Product Code
LRN  
Date Received11/05/1986
Decision Date 05/20/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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