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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cylinder, compressed gas, and valve
510(k) Number K062300
Device Name OX-SOX, MODEL C, D, E,
Applicant
PATTIENT SAFETY INNOVATIONS, LLP
10051 E HIGHLAND RD
SUITE 29-202
HOWELL,  MI  48843 -6317
Applicant Contact ERIK STALHANDSKE
Correspondent
PATTIENT SAFETY INNOVATIONS, LLP
10051 E HIGHLAND RD
SUITE 29-202
HOWELL,  MI  48843 -6317
Correspondent Contact ERIK STALHANDSKE
Regulation Number868.2700
Classification Product Code
ECX  
Date Received08/08/2006
Decision Date 11/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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