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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863554
Device Name THACKRAY CRUCIATE SPARING KNEE CS-1
Applicant
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Date Received09/12/1986
Decision Date 10/06/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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