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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Reservoir
510(k) Number K830056
Device Name ARTEC TWIST VALVE
Applicant
ARTEC ENVIRONMENTAL MONITORING DIVISION
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ARTEC ENVIRONMENTAL MONITORING DIVISION
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5320
Classification Product Code
BTC  
Date Received01/06/1983
Decision Date 03/09/1983
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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