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510(k) K883197

IOL IMPLANTATION FORCEPS by D & D Surgical — Product Code HNR

K883197 is an FDA 510(k) premarket notification submitted by D & D Surgical for the device "IOL IMPLANTATION FORCEPS". The FDA issued a decision of Substantially Equivalent on August 22, 1988. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1988
Date Received
July 28, 1988
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 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)
  • K880274 — ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (February 5, 1988)
  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K864183 — OPHTHALMIC SURGICAL INSTRUMENTS (November 28, 1986)
  • K864071 — FAULKNER FORCEPS (November 13, 1986)

FDA data resources