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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name circuit, breathing (w connector, adaptor, y piece)
510(k) Number K945565
Device Name SPIRO-FLEX
Applicant
INHALATION PLASTICS
3217 N. KILPATRICK AVE.
CHICAGO,  IL  60641
Applicant Contact JAMES LEKKAS
Correspondent
INHALATION PLASTICS
3217 N. KILPATRICK AVE.
CHICAGO,  IL  60641
Correspondent Contact JAMES LEKKAS
Regulation Number868.5240
Classification Product Code
CAI  
Date Received09/16/1994
Decision Date 01/13/1995
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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