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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nebulizer (direct patient interface)
510(k) Number K923559
Device Name STERI-CATH MDI
Applicant
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
CONCORD/PORTEX
15 KITT ST.
KEENE,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/17/1992
Decision Date 10/25/1993
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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