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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Box, Battery, Pocket
510(k) Number K891927
Device Name TELEMETRY POWER PACK MODEL 2
Applicant
Lucas & Rhea Mfg.
Rte. 1, Box 12a
Lavinia,  TN  38348
Applicant Contact VIRGINIA RHEA
Correspondent
Lucas & Rhea Mfg.
Rte. 1, Box 12a
Lavinia,  TN  38348
Correspondent Contact VIRGINIA RHEA
Regulation Number876.1500
Classification Product Code
FCP  
Date Received03/28/1989
Decision Date 04/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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