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510(k) K864962

OBERTO MOUTH PROP by Medovations, Inc. — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1987
Date Received
December 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
Submission Type

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  • K954352 — BITE BLOCK (January 25, 1996)
  • K941856 — PREMIER PROMAX BITE GUARD (April 5, 1995)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)