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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K963481
Device Name ANODYNE CC
Applicant
Heyer America, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Applicant Contact ED RANSOM
Correspondent
Heyer America, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Correspondent Contact ED RANSOM
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/03/1996
Decision Date 08/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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