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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker Lead Adaptor
510(k) Number K781864
Device Name ADAPTER KIT
Applicant
Daig Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Daig Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3620
Classification Product Code
DTD  
Date Received11/06/1978
Decision Date 12/19/1978
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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