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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 K984117
Device Name INNOVA TELESCOPIC DISTRACTOR
Applicant
INNOVA CORP.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
INNOVA CORP.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number872.4760
Classification Product Code
MQN  
Date Received11/17/1998
Decision Date 02/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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