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510(k) K882402

RETRACTIVE INCISION MICROMETER (RIM) GUAGE by Optical Center — Product Code HNN

K882402 is an FDA 510(k) premarket notification submitted by Optical Center for the device "RETRACTIVE INCISION MICROMETER (RIM) GUAGE". The FDA issued a decision of Substantially Equivalent on August 22, 1988. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1988
Date Received
June 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances for product code HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)
  • K863725 — CATARACT DIAMOND KNIFE (October 31, 1986)

FDA data resources