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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 K871136
Device Name HEARTSTART 2000, MANUAL DEFIBRILLATOR
Applicant
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Applicant Contact BRUCE G HAGGER
Correspondent
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Correspondent Contact BRUCE G HAGGER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received03/20/1987
Decision Date 05/12/1987
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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