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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K981412
Device Name M1145 (UPS1-1.25K-1G-MP) UPS
Applicant
CLARY CORP.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
CLARY CORP.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/20/1998
Decision Date 11/23/1998
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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