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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K860686
Device Name FACEGLOV,ANESTHETIC GAS MASK
Applicant
Loran , Ltd.
15672 E. Jefferson Ave.
Aurora,  CO  80013
Applicant Contact RICHARD E BONCEK
Correspondent
Loran , Ltd.
15672 E. Jefferson Ave.
Aurora,  CO  80013
Correspondent Contact RICHARD E BONCEK
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received02/25/1986
Decision Date 04/30/1986
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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