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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 K945901
Device Name DIRECT VIEW 2001 FIBERLIGHT
Applicant
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Applicant Contact KATHY L HANN
Correspondent
MERCURY MEDICAL
11300-A 49TH ST. NORTH
CLEARWATER,  FL  34622 -4800
Correspondent Contact KATHY L HANN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received12/02/1994
Decision Date 12/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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