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510(k) K943968

TUNNELER by Denver Biomedicals, Inc. — Product Code MDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
August 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K811577 — CROUCH CORNEAL PROTECTOR (August 7, 1981)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (July 1, 1981)

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