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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Prosthesis
510(k) Number K870848
Device Name SCHULTZ METACARPAL COMPONENT DRIVER
Applicant
WARSAW ORTHOPEDIC, INC.
P.O. BOX 1157
WARSAW,  IN  46580
Applicant Contact JAMES RITTER
Correspondent
WARSAW ORTHOPEDIC, INC.
P.O. BOX 1157
WARSAW,  IN  46580
Correspondent Contact JAMES RITTER
Regulation Number888.4540
Classification Product Code
HWR  
Date Received03/03/1987
Decision Date 03/13/1987
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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