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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 K811858
Device Name KHI CPRAM BREATHING CIRCUIT
Applicant
KHI, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KHI, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5240
Classification Product Code
CAI  
Date Received07/01/1981
Decision Date 07/16/1981
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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