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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 K041852
Device Name MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
Applicant
Minrad, Inc.
847 Main St.
Buffalo,  NY  14203
Applicant Contact JOHN MCNEIRNEY
Correspondent
Minrad, Inc.
847 Main St.
Buffalo,  NY  14203
Correspondent Contact JOHN MCNEIRNEY
Regulation Number868.5540
Classification Product Code
CCW  
Date Received07/08/2004
Decision Date 11/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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