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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K030261
Device Name BATTERY, RECHARGEABLE
Applicant
ACCESS BATTERY, INC.
5357 HIGHWAY 86
ELIZABETH,  CO  80107
Applicant Contact ALEXANDER B HENDERSON
Correspondent
ACCESS BATTERY, INC.
5357 HIGHWAY 86
ELIZABETH,  CO  80107
Correspondent Contact ALEXANDER B HENDERSON
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/24/2003
Decision Date 04/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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