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510(k) K984117

INNOVA TELESCOPIC DISTRACTOR by Innova Corp. — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1999
Date Received
November 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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  • K926354 — ENDO-PORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (February 13, 1995)
  • K915361 — THE BODY BUGGY (December 20, 1991)

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