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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 K924627
Device Name XTEND CIRCUITS (TM)
Applicant
Arc Medical, Inc.
735 Park N. Blvd.
Bldg. 126
Clarkston,  GA  30021
Applicant Contact HAL NORRIS
Correspondent
Arc Medical, Inc.
735 Park N. Blvd.
Bldg. 126
Clarkston,  GA  30021
Correspondent Contact HAL NORRIS
Regulation Number868.5240
Classification Product Code
CAI  
Date Received09/14/1992
Decision Date 04/07/1993
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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