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510(k) K903536

SMALL JOINT INSTRUMENTS (SCISSOR HANDLE) by Leonard Medical, Inc. — Product Code LOS

K903536 is an FDA 510(k) premarket notification submitted by Leonard Medical, Inc. for the device "SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)". The FDA issued a decision of Substantially Equivalent on September 6, 1990. Leonard Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1990
Date Received
August 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Leonard Medical, Inc.

  • K951854 — LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (June 21, 1995)
  • K895685 — SMALL JOINT HAND INSTRUMENTS (October 16, 1989)
  • K884308 — MANDIBLE MANIPULATOR (March 31, 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 LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)

FDA data resources