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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name strap, head, gas mask
510(k) Number K944949
Device Name GENERAL ANESTHESIA SYSTEM
Applicant
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Applicant Contact JING ZHANG
Correspondent
VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA,  NJ  07512
Correspondent Contact JING ZHANG
Regulation Number868.5560
Classification Product Code
BTK  
Date Received10/07/1994
Decision Date 11/14/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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