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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K945894
Device Name MASK, GAS, ANESTHETIC
Applicant
Hans Rudolph, Inc.
7200 Wyandotte
Kansas City,  MO  64114
Applicant Contact KEVIN RUDOLPH
Correspondent
Hans Rudolph, Inc.
7200 Wyandotte
Kansas City,  MO  64114
Correspondent Contact KEVIN RUDOLPH
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received12/02/1994
Decision Date 01/27/1995
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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