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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K030822
Device Name 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
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 Number868.5905
Classification Product Code
BZD  
Date Received03/14/2003
Decision Date 06/03/2003
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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