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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K971374
Device Name GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
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 Number884.1690
Classification Product Code
HIH  
Date Received04/14/1997
Decision Date 05/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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