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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 K970619
Device Name GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
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 Received02/18/1997
Decision Date 11/19/1997
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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