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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 K062523
Device Name TRU-MR LARYNGOSCOPE SET
Applicant
TRUPHATEK INTERNATIONAL, LTD.
3460 POINTE CREEK CT.
# 102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
TRUPHATEK INTERNATIONAL, LTD.
3460 POINTE CREEK CT.
# 102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received08/28/2006
Decision Date 11/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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