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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K925701
Device Name MINIPACK 911-STC
Applicant
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Applicant Contact MARY J BILGUTAY
Correspondent
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER,  FL  33755
Correspondent Contact MARY J BILGUTAY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/12/1992
Decision Date 08/11/1994
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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