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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K912835
Device Name MINI-PACK 911 SERIES
Applicant
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Applicant Contact MARY J BILGUTAY
Correspondent
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Correspondent Contact MARY J BILGUTAY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/26/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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