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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K993282
Device Name IPI HUMIDIFIER CHAMBER
Applicant
I.P.I. MEDICAL PRODUCTS
3217 N. KILPATRICK AVE.
CHICAGO,  IL  60641
Applicant Contact MAZH SAID, PH.D
Correspondent
I.P.I. MEDICAL PRODUCTS
3217 N. KILPATRICK AVE.
CHICAGO,  IL  60641
Correspondent Contact MAZH SAID, PH.D
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/30/1999
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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