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510(k) K823767

ERG-JET ELECTRODE by Life-Tech Intl., Inc. — Product Code HLF

K823767 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "ERG-JET ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 8, 1983. The device falls under product code HLF (Device, Measuring, Lens Radius, Ophthalmic), a Class I device regulated under 21 CFR 886.1430. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
December 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Measuring, Lens Radius, Ophthalmic
Device Class
Class I
Regulation Number
886.1430
Review Panel
OP
Submission Type

Other clearances by Life-Tech Intl., Inc.

  • K001129 — PROLONG, MODELS PL50, PL100, PL150 (July 6, 2000)
  • K954505 — EZ STIM (December 10, 1996)
  • K955031 — MAXISTIM (December 10, 1996)
  • K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER (November 30, 1995)
  • K954341 — URODYNAMICS TUBING AND INFUSION SETS (October 17, 1995)
  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
  • K953353 — UROVISION JANUS (September 8, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)

Other clearances for product code HLF

  • K930437 — MARCO STANDARD RADIUSGAUGES (August 9, 1993)
  • K862517 — BAUSCH & LOMB CONTACT LENS VIEWER (August 11, 1986)

FDA data resources