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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 K934462
Device Name ADULT ANESTHESIA BREATHING CIRCUIT KITS
Applicant
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Applicant Contact ROBERT L STONE
Correspondent
Zefon Medical Products
5350 Southwest First Ln.
Ocala,  FL  34474
Correspondent Contact ROBERT L STONE
Regulation Number868.5240
Classification Product Code
CAI  
Date Received09/13/1993
Decision Date 03/01/1994
Decision Substantially Equivalent - Kit (SESK)
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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