Home / 510(k) Clearances / K930094

510(k) K930094

AUKUSLEEVE by Aukland Medical Plastics, Inc. — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1993
Date Received
January 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Aukland Medical Plastics, Inc.

  • K953610 — AUKULYTE (September 26, 1995)
  • K930840 — POST-MYDS(TM) (March 1, 1994)

Other clearances for product code EJB

  • K140144 — BENDA WEDGE (July 8, 2014)
  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)
  • K981234 — FLARE,FILE, FILL (June 5, 1998)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)
  • K823913 — SOFT GRIP UNI-HANDLE (January 26, 1983)