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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 K932589
Device Name PEDIATRIC GAS SAMPLING CIRCUITS
Applicant
Merit Medical Systems, Inc.
8102 Woodland Dr/.
Indianapolis,  IN  46278
Applicant Contact ROBERT RICHMOND
Correspondent
Merit Medical Systems, Inc.
8102 Woodland Dr/.
Indianapolis,  IN  46278
Correspondent Contact ROBERT RICHMOND
Regulation Number868.5240
Classification Product Code
CAI  
Date Received05/27/1993
Decision Date 07/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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