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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 K811015
Device Name POSITIVE CLOSURE ANESTHETIC VALVE
Applicant
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHOPEDIC SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5240
Classification Product Code
CAI  
Date Received04/15/1981
Decision Date 05/15/1981
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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