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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K912578
Device Name 20CM/H20 PEEP VALVE
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact DENNIS IRLBECK
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact DENNIS IRLBECK
Regulation Number868.5965
Classification Product Code
BYE  
Date Received06/12/1991
Decision Date 09/11/1991
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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