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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K993072
Device Name SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
Applicant
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact Sew-Wah Tay
Correspondent
Survivalink Corp.
5420 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact Sew-Wah Tay
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/14/1999
Decision Date 12/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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