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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lock, Wire, And Ligature, Intraoral
510(k) Number K925106
Device Name IMPLANTABLE PULSE GENERATORS
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact JOHN M OTTO
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact JOHN M OTTO
Regulation Number872.4600
Classification Product Code
DYX  
Date Received10/09/1992
Decision Date 10/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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