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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K971781
Device Name GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
Applicant
Wilson Greatbatch Technologies, Inc.
4100 Barton Rd.
Clarence,  NY  14031
Applicant Contact GARY J SFEIR
Correspondent
Wilson Greatbatch Technologies, Inc.
4100 Barton Rd.
Clarence,  NY  14031
Correspondent Contact GARY J SFEIR
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/14/1997
Decision Date 11/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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