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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 K062231
Device Name MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
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 Received08/02/2006
Decision Date 08/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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