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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 K894355
Device Name DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
Applicant
Phycon
635 Gillette Ave.
Tampa,  FL  33617
Applicant Contact C KLESSY
Correspondent
Phycon
635 Gillette Ave.
Tampa,  FL  33617
Correspondent Contact C KLESSY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/14/1989
Decision Date 12/12/1989
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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