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510(k) K003522

SALUTE by Onux Medical, Inc. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2001
Date Received
November 15, 2000
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)
  • K014286 — SALUTE, MODEL 3022 (March 8, 2002)
  • K010620 — ENDOSCOPIC STAPLE REMOVAL INSTRUMENT (May 17, 2001)

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