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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 K851531
Device Name 4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG
Applicant
SIGMA MEDICAL, INC.
5377 WEST 86TH STREET, BLDG.
#8
INDIANAPOLIS,  IN  46268
Correspondent
SIGMA MEDICAL, INC.
5377 WEST 86TH STREET, BLDG.
#8
INDIANAPOLIS,  IN  46268
Regulation Number868.5240
Classification Product Code
CAI  
Date Received04/16/1985
Decision Date 04/25/1985
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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