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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 K864257
Device Name TELEPHONE DEFIBRILLATOR SYSTEM
Applicant
MEDPHONE CORP.
C/O DICKSTEIN/SHAPIRO & MORIN
2101 L STREET, N.W.
WASHINGTON,  DC  20037
Applicant Contact RODNEY MUNSEY
Correspondent
MEDPHONE CORP.
C/O DICKSTEIN/SHAPIRO & MORIN
2101 L STREET, N.W.
WASHINGTON,  DC  20037
Correspondent Contact RODNEY MUNSEY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/29/1986
Decision Date 11/27/1987
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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