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510(k) K821689

LEBANON MICROSCOPE by The Lebanon Corp. — Product Code EPT

K821689 is an FDA 510(k) premarket notification submitted by The Lebanon Corp. for the device "LEBANON MICROSCOPE". The FDA issued a decision of Substantially Equivalent on July 9, 1982. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. The Lebanon Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1982
Date Received
June 8, 1982
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 by The Lebanon Corp.

  • K841652 — OCULAR PRESSURE APPLICATOR (June 1, 1984)
  • K820526 — RELIEF VALVE-HONAN INTRAOC. PRESSURE (March 25, 1982)

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE (November 18, 1993)
  • 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)

FDA data resources