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510(k) K931284

MICRODYNE OFFICE SURGICAL MICROSCOPE by Microdyne, Inc. — Product Code EPT

K931284 is an FDA 510(k) premarket notification submitted by Microdyne, Inc. for the device "MICRODYNE OFFICE SURGICAL MICROSCOPE". The FDA issued a decision of Substantially Equivalent on November 18, 1993. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1993
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K933310 — MICRINS CONTRAST BACKGROUND MATERIAL (August 19, 1993)
  • K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (September 20, 1990)
  • K883581 — OPMI CS (September 13, 1988)
  • K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM (June 23, 1988)
  • K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (April 30, 1986)
  • K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (March 25, 1985)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K823011 — VC III (November 8, 1982)
  • K822561 — MICROSCOPE (September 14, 1982)

FDA data resources