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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 K874746
Device Name SEALFLEX MASK
Applicant
Engineered Medical Systems
P.O. Box 40543
Indianapolis,  IN  46240
Applicant Contact JEFF QUINN
Correspondent
Engineered Medical Systems
P.O. Box 40543
Indianapolis,  IN  46240
Correspondent Contact JEFF QUINN
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received11/18/1987
Decision Date 12/21/1987
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
Recalls CDRH Recalls
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