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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Breathing Tube
510(k) Number K834089
Device Name COMFIT
Applicant
ACKRAD LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ACKRAD LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5280
Classification Product Code
JAY  
Date Received11/28/1983
Decision Date 12/29/1983
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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