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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 K852314
Device Name #6010 NON-CONDUCTIVE VENTILATOR CIRCUIT
Applicant
SIGMA MEDICAL, INC.
5377 WEST 86TH STREET, BLDG.
#8
INDIANAPOLIS,  IN  46268
Applicant Contact DAVID L SCHROEDER
Correspondent
SIGMA MEDICAL, INC.
5377 WEST 86TH STREET, BLDG.
#8
INDIANAPOLIS,  IN  46268
Correspondent Contact DAVID L SCHROEDER
Regulation Number868.5240
Classification Product Code
CAI  
Date Received05/29/1985
Decision Date 08/13/1985
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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