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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
Predetermined Change
Control Plan Authorized		 No
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