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510(k) K760949

CHARLES IRRIGATING FUNDUS CONTACT LENS by Richard'S Medical Equip., Inc. — Product Code HJI

K760949 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "CHARLES IRRIGATING FUNDUS CONTACT LENS". The FDA issued a decision of Substantially Equivalent on November 11, 1976. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 11, 1976
Date Received
November 1, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Fundus, Hruby, Diagnostic
Device Class
Class I
Regulation Number
886.1395
Review Panel
OP
Submission Type

Other clearances by Richard'S Medical Equip., Inc.

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (March 9, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT FEMORAL PROSTHES (March 8, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K830153 — RICHARDS INTRA-ARTICULAR SHAVER BLADES (February 28, 1983)
  • K830154 — COLLES FRACTURE FRAME (February 2, 1983)
  • K823728 — SPECTRON POLYETHYLENE ACCTUBULAR COMPON (January 21, 1983)

Other clearances for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K901839 — 60 FUNDUS CAMERA CF-60UV (July 5, 1990)
  • K902138 — STRIPE PROJECTOR (July 5, 1990)
  • K897186 — LASER IMAGING WORK STATION (March 12, 1990)
  • K820223 — OMS QUARTZ INFUSION CONTACT LENS (February 5, 1982)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K802971 — LANDERS CONTACT LENS (February 5, 1981)

FDA data resources