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510(k) K832912

GELENDER VACUUM FIXATION RING SYS by Miami Eye Technology, Inc. — Product Code HNH

K832912 is an FDA 510(k) premarket notification submitted by Miami Eye Technology, Inc. for the device "GELENDER VACUUM FIXATION RING SYS". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code HNH (Ring, Ophthalmic (Flieringa)), a Class I device regulated under 21 CFR 886.4350. Miami Eye Technology, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
August 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring, Ophthalmic (Flieringa)
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Miami Eye Technology, Inc.

  • K841101 — CLAYMAN-PAREL CAPSULE COUPEUR (May 16, 1984)
  • K832996 — SURGICAL IOP MONITOR (November 28, 1983)
  • K832997 — EPA AUTOMATED INFUSION POLE (October 4, 1983)
  • K832911 — ABBOTT GLOBE HOLDER (September 29, 1983)
  • K831702 — RARE-EARTH INTRA-OCULAR MAGNET (June 30, 1983)

Other clearances for product code HNH

  • K912269 — LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (August 7, 1991)
  • K912268 — LANDERS NOTCHED VITRECTOMY LENS RING (August 7, 1991)
  • K912151 — LANDERS THREE STRUT VITRECTOMY LENS RING (July 25, 1991)
  • K902496 — LANDERS VITRECTOMY LENS RING W/INFUSION (July 24, 1990)
  • K863775 — RK VACUUM FIXATION RING SYSTEM (October 20, 1986)
  • K850991 — LANDERS VITRECTOMY LENS RING SYSTEMS (March 29, 1985)

FDA data resources