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510(k) K930439

MARCO SURGISCOPE OPERATION MICROSCOPES by Marco Ophthalmic, Inc. — Product Code HRM

K930439 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO SURGISCOPE OPERATION MICROSCOPES". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Marco Ophthalmic, Inc.

  • K943234 — MS-30 AUTOMATIC PERIMETER (July 27, 1994)
  • K930437 — MARCO STANDARD RADIUSGAUGES (August 9, 1993)
  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K930438 — MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS (August 9, 1993)
  • K930442 — MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS (August 9, 1993)
  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)
  • K930441 — MARCO STANDARD LENSMETERS 101,201 (July 6, 1993)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K930443 — MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE (July 6, 1993)

Other clearances for product code HRM

  • K932720 — HM-0970 (September 7, 1993)
  • K920641 — ALCON OPERATING MICROSCOPES (October 9, 1992)
  • K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500 (February 3, 1992)
  • K891584 — S 22 INSTRUMENT STAND (June 8, 1989)
  • K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (April 11, 1989)
  • K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (December 16, 1985)
  • K853855 — XTAL X-150 OPERATING MICROSCOPE (October 15, 1985)
  • K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1 (July 30, 1985)
  • K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (June 3, 1985)
  • K850270 — CORNEAL LIGHT SHIELD (May 31, 1985)

FDA data resources