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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 K020759
Device Name 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
Applicant
Hans Rudolph, Inc.
7205 Central
Kansas City,  MO  64114
Applicant Contact KEVIN RUDOLPH
Correspondent
Hans Rudolph, Inc.
7205 Central
Kansas City,  MO  64114
Correspondent Contact KEVIN RUDOLPH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/07/2002
Decision Date 08/13/2002
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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