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510(k) K092855

MILTEX MEMBRANE TACK KIT by Miltex, Inc. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2009
Date Received
September 16, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

Other clearances by Miltex, Inc.

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  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K072563 — MILTEX RIGID CONTAINER SYSTEMS (February 12, 2008)
  • K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) (December 12, 2006)
  • K052018 — MILTEX LIGATING CLIP (November 4, 2005)
  • K050570 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM (July 25, 2005)
  • K043013 — MILTEX LAPAROSCOPIC INSTRUMENTS (March 4, 2005)
  • K013888 — FIXATION (STEINMANN) PINS (May 1, 2002)
  • K954185 — RE-BAG MULTI-USE POUCH, LARGE & SMALL (December 4, 1995)
  • K823319 — DENTAL INSTRUMENTS - SCALERS (November 24, 1982)

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