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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K940712
Device Name PPM III
Applicant
O-Two Systems Intl., Inc.
7575 Kimbel St., Unit 5
Mississauga
Ontario L5s 1c8,  CA
Applicant Contact KEVIN BOWDEN
Correspondent
O-Two Systems Intl., Inc.
7575 Kimbel St., Unit 5
Mississauga
Ontario L5s 1c8,  CA
Correspondent Contact KEVIN BOWDEN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received02/17/1994
Decision Date 11/14/1994
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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