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510(k) K884308

MANDIBLE MANIPULATOR by Leonard Medical, Inc. — Product Code EKJ

K884308 is an FDA 510(k) premarket notification submitted by Leonard Medical, Inc. for the device "MANDIBLE MANIPULATOR". The FDA issued a decision of Substantially Equivalent on March 31, 1989. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Leonard Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1989
Date Received
October 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Leonard Medical, Inc.

  • K951854 — LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (June 21, 1995)
  • K903536 — SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) (September 6, 1990)
  • K895685 — SMALL JOINT HAND INSTRUMENTS (October 16, 1989)
  • K884314 — LEONARD MEDICAL 1.7MM ARTHROSCOPE (March 13, 1989)
  • K873139 — VARUS AND VALGUS LEG HOLDER (September 16, 1987)
  • K864117 — SUPPORT ARM (November 3, 1986)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)

FDA data resources