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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K920990
Device Name LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)
Applicant
Raco Products Co.
5504 State Rd.
Cleveland,  OH  44134
Applicant Contact GERALD J CAHILL
Correspondent
Raco Products Co.
5504 State Rd.
Cleveland,  OH  44134
Correspondent Contact GERALD J CAHILL
Regulation Number870.5300
Classification Product Code
LDD  
Date Received03/02/1992
Decision Date 07/06/1992
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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