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510(k) K843992

CILCOR OPHTHALMIC INSTRUMENTS by Cilco, Inc. — Product Code HNR

K843992 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "CILCOR OPHTHALMIC INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on November 21, 1984. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1984
Date Received
October 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Cilco, Inc.

  • K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (May 2, 1986)
  • K854969 — CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (February 27, 1986)
  • K844249 — K-SOL (April 30, 1985)
  • K843319 — CILCO I/A SURGICAL PACK (February 14, 1985)
  • K843447 — CILCO DIAMOND KNIFE (October 5, 1984)
  • K841099 — OCTOPUS 500/500E (June 19, 1984)
  • K840475 — CYSTOTOME, 140-S (April 5, 1984)
  • K832405 — OPTHALMIC ENDOSCOPE (November 21, 1983)
  • K827371 — CILCO ASCAN (July 9, 1982)
  • K820933 — CILCO I/A HANDPIECE (June 14, 1982)

Other clearances for product code HNR

  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K895434 — ALCON FOLDING FORCEPS (December 4, 1989)
  • K891487 — SOFT LENS FOLDING BLOCK (August 15, 1989)
  • K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR (June 16, 1989)
  • K885230 — MCDONALD FOLDING FORCEPS (May 17, 1989)
  • K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (September 12, 1988)
  • K883197 — IOL IMPLANTATION FORCEPS (August 22, 1988)
  • K880274 — ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (February 5, 1988)
  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K864183 — OPHTHALMIC SURGICAL INSTRUMENTS (November 28, 1986)

FDA data resources