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510(k) K011373

INSTRUMENT DAMPING PORT by Medcanica, Inc. — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2001
Date Received
May 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

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  • K991064 — METACARPAL FIXATION SYSTEM (June 23, 1999)

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