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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 K915558
Device Name IAS ANESTHESIA MASK
Applicant
IAS
386 BROADWAY
NEWBURGH,  NY  12550
Applicant Contact DANIEL J SLHEEHAN
Correspondent
IAS
386 BROADWAY
NEWBURGH,  NY  12550
Correspondent Contact DANIEL J SLHEEHAN
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received12/11/1991
Decision Date 04/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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