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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K133528
Device Name H&H EMERGENCY CRICOTHYROTOMY KIT
Applicant
H&H MEDICAL CORPORATION
290 TURNPIKE RD.
SUITE 200
WESTBOROUGH,  MA  01581
Applicant Contact J. Lawrence Stevens
Correspondent
H&H MEDICAL CORPORATION
290 TURNPIKE RD.
SUITE 200
WESTBOROUGH,  MA  01581
Correspondent Contact J. Lawrence Stevens
Regulation Number868.5800
Classification Product Code
JOH  
Date Received11/15/2013
Decision Date 07/03/2014
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
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