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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K872053
Device Name KEYFILL
Applicant
Mayfield Instruments, Ltd.
93 Sumach St. Toronto
Ontario, M5a3ja,  CA
Applicant Contact GERRY BUY
Correspondent
Mayfield Instruments, Ltd.
93 Sumach St. Toronto
Ontario, M5a3ja,  CA
Correspondent Contact GERRY BUY
Regulation Number868.5880
Classification Product Code
CAD  
Date Received06/01/1987
Decision Date 07/01/1987
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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