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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K861409
Device Name SYNCARE TEMPORARY CARDIAC PACING WIRE
Applicant
Gyneco, Inc.
51 Chubb Way
Somerville,  NJ  08876
Applicant Contact BUDAY, PH.D.
Correspondent
Gyneco, Inc.
51 Chubb Way
Somerville,  NJ  08876
Correspondent Contact BUDAY, PH.D.
Regulation Number870.3680
Classification Product Code
LDF  
Date Received04/15/1986
Decision Date 05/05/1986
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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