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510(k) K850706

F-SERIES IMPLANT by Omni Intl., Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
February 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Omni Intl., Inc.

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  • K853255 — OMNIMED I.V. SOLUTION ADMIN. SET (August 23, 1985)
  • K851938 — OMNIMED SURGICAL GOWN (June 28, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR (May 23, 1985)
  • K850112 — OMNIMED IV SOLUTION ADMINISTRATION SET (February 22, 1985)
  • K850066 — OMNIMED NASAL OXYGEN CANNULA (January 24, 1985)
  • K831147 — OMNIPROBE ELECTRICAL NERVE STIMULATOR (July 18, 1983)
  • K821523 — OMNI TENS (June 16, 1982)

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