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510(k) K014286

SALUTE, MODEL 3022 by Onux Medical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
December 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type

Other clearances by Onux Medical, Inc.

  • K023372 — NON-BIOABSORBABLE STAPLE (December 27, 2002)
  • K022777 — MANUAL TOUCHE SYSTEM (November 19, 2002)
  • K010620 — ENDOSCOPIC STAPLE REMOVAL INSTRUMENT (May 17, 2001)
  • K003522 — SALUTE (February 13, 2001)

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