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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K945674
Device Name MANDIBULAR BONE DISTRACTOR
Applicant
Howmedica Corp.
C/Manuel Tovar, 25
Madrid,  ES 28034
Applicant Contact MARY C SPICER
Correspondent
Howmedica Corp.
C/Manuel Tovar, 25
Madrid,  ES 28034
Correspondent Contact MARY C SPICER
Regulation Number872.4760
Classification Product Code
MQN  
Date Received11/18/1994
Decision Date 06/02/1995
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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