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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 K954661
Device Name THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,
Applicant
ZIPPER MEDICAL, INC.
10109 DAY AVE.
SILVER SPRING,  MD  20910 -1041
Applicant Contact GREG DOLL
Correspondent
ZIPPER MEDICAL, INC.
10109 DAY AVE.
SILVER SPRING,  MD  20910 -1041
Correspondent Contact GREG DOLL
Regulation Number868.5800
Classification Product Code
JOH  
Subsequent Product Code
CBH  
Date Received10/10/1995
Decision Date 01/19/1996
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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