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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 K000995
Device Name NARKOMAT, MODEL 2000
Applicant
Heyer America, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ART WARD
Correspondent
Heyer America, Inc.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ART WARD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/28/2000
Decision Date 10/11/2000
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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