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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 K803086
Device Name MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
Applicant
Craig & Craig, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Craig & Craig, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
LDF  
Date Received12/08/1980
Decision Date 07/01/1981
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
Recalls CDRH Recalls
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