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510(k) K930447

MARCO H AND TS-1 INSTRUMENT TABLES by Marco Ophthalmic, Inc. — Product Code HRJ

K930447 is an FDA 510(k) premarket notification submitted by Marco Ophthalmic, Inc. for the device "MARCO H AND TS-1 INSTRUMENT TABLES". The FDA issued a decision of Substantially Equivalent on July 6, 1993. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Marco Ophthalmic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Instrument, Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.4855
Review Panel
OP
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)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 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 HRJ

  • K922242 — 910T MONTORIZED INSTRUMENT TABLE (September 30, 1992)
  • K912134 — TBD, LENS MEASURING DEVICE (July 25, 1991)
  • K853744 — TECHNA VISION, INC.ELECTRIC TABLE (October 17, 1985)
  • K853359 — RELIANCE 1379 (September 24, 1985)
  • K841760 — WOODLYN CLASSIC INSTRUMENT STAND (June 19, 1984)
  • K833820 — MACHEMER/TANO ROTATING (January 4, 1984)

FDA data resources