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510(k) K922292

LUNDEEN SUBTALAR PEG IMPLANT by Sgarlato Laboratories, Inc. — Product Code MJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1992
Date Received
May 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Subtalar, Plug, Polymer
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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Other clearances for product code MJW

  • K033046 — SUBTALAR PEG IMPLANT (December 23, 2003)