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510(k) K823320

DENTAL INSTRUMENTS - BONE CHISELS by Miltex, Inc. — Product Code EML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1982
Date Received
November 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel, Bone, Surgical
Device Class
Class I
Regulation Number
872.4565
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)

Other clearances for product code EML

  • K851715 — 830/4 TO 848/7 VARIOUS TYPES CHISELS (June 11, 1985)