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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 K881067
Device Name NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
Applicant
Medesign, Inc.
685 Bloomfield Ave.
Verona,  NJ  07044
Applicant Contact ISSIE KROLL
Correspondent
Medesign, Inc.
685 Bloomfield Ave.
Verona,  NJ  07044
Correspondent Contact ISSIE KROLL
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received03/14/1988
Decision Date 03/24/1988
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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