Home / 510(k) Clearances / K945110

510(k) K945110

KOLBERG OPHTHALMIC CONFORMER by Kolberg Ocular Products, Inc. — Product Code HQN

K945110 is an FDA 510(k) premarket notification submitted by Kolberg Ocular Products, Inc. for the device "KOLBERG OPHTHALMIC CONFORMER". The FDA issued a decision of Substantially Equivalent on January 13, 1995. The device falls under product code HQN (Conformer, Ophthalmic), a Class II device regulated under 21 CFR 886.3130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1995
Date Received
October 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conformer, Ophthalmic
Device Class
Class II
Regulation Number
886.3130
Review Panel
OP
Submission Type

Other clearances for product code HQN

  • K972034 — MEDPOR OCULAR CONFORMER (January 20, 1998)
  • K970318 — OCULAR CONFORMER (July 7, 1997)
  • K970319 — OCULAR CONFORMER (July 7, 1997)
  • K921221 — STERILE/SINGLE USE SYMBLEPHARON RING (July 17, 1992)
  • K921229 — STERILE/SINGLE USE OPHTHALMIC CONFORMERS (June 9, 1992)
  • K772168 — MOLDEYE (November 30, 1977)

FDA data resources