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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K905450
Device Name ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact ALBERTO VELEZ
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact ALBERTO VELEZ
Regulation Number868.5240
Classification Product Code
CAI  
Date Received12/05/1990
Decision Date 07/01/1991
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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