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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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