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510(k) K833820

MACHEMER/TANO ROTATING by Optical Micro Systems, Inc. — Product Code HRJ

K833820 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "MACHEMER/TANO ROTATING". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1984
Date Received
November 2, 1983
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 Optical Micro Systems, Inc.

  • K950218 — OMS SLIMLINE PHACO HANDPIECE (July 17, 1995)
  • K946054 — DIPLOMAX (July 11, 1995)
  • K935223 — OPHTHALMIC SURGICAL SYSTEM (March 14, 1994)
  • K935226 — I/V POLE (February 16, 1994)
  • K935003 — ELECTRIC I/V POLE OR EIVP2 (January 25, 1994)
  • K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE (February 12, 1987)
  • K844373 — O.M.S. ULTRA-PHACO (December 19, 1985)
  • K844448 — OMS/GONVERS RETINAL PERFORATOR (August 21, 1985)
  • K844895 — OMS SILICONE OIL INJECTOR (June 24, 1985)
  • K844467 — OMS CRYO (February 22, 1985)

Other clearances for product code HRJ

  • K930447 — MARCO H AND TS-1 INSTRUMENT TABLES (July 6, 1993)
  • 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)

FDA data resources