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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K970256
Device Name INTRAORAL MANDIBULAR DISTRACTION DEVICE
Applicant
Medicon EG
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN, ESQ.
Correspondent
Medicon EG
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN, ESQ.
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/23/1997
Decision Date 03/11/1997
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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