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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Non-Rebreathing
510(k) Number K960401
Device Name ULTIMATE SEAL
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 Number868.5570
Classification Product Code
KGB  
Date Received01/29/1996
Decision Date 06/20/1996
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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