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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K971377
Device Name GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
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 Number868.5540
Classification Product Code
CCW  
Date Received04/14/1997
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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