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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 K895009
Device Name GEL-TAC(R)
Applicant
Padeco, Inc.
P.O. Box 2106
Lake Oswego,  OR  97035
Applicant Contact JOSEPH M MERTZ
Correspondent
Padeco, Inc.
P.O. Box 2106
Lake Oswego,  OR  97035
Correspondent Contact JOSEPH M MERTZ
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/08/1989
Decision Date 12/13/1989
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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