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510(k) K983882

MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 by Micro-Medical Devices, Inc. — Product Code HXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
November 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Micro-Medical Devices, Inc.

  • K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5 (February 14, 2001)
  • K963675 — THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE (January 27, 1997)
  • K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (September 14, 1995)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
  • K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE (March 28, 1995)
  • K940141 — LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH (May 19, 1994)
  • K936213 — ARTHROSCOPES AND ACCESSORIES (May 18, 1994)

Other clearances for product code HXR

  • K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM (November 25, 1987)
  • K872281 — RAYLOR FUSION FUNNEL (November 2, 1987)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)