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510(k) K891487

SOFT LENS FOLDING BLOCK by Western Medical Products, Inc. — Product Code HNR

K891487 is an FDA 510(k) premarket notification submitted by Western Medical Products, Inc. for the device "SOFT LENS FOLDING BLOCK". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code HNR (Forceps, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Western Medical Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
March 17, 1989
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 Western Medical Products, Inc.

  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K843589 — TICLIP STERIAL DISPOSABLE (October 24, 1984)

Other clearances for product code HNR

  • K022835 — STEPHENS DISPOSABLE FORCEPS (November 1, 2002)
  • K895434 — ALCON FOLDING FORCEPS (December 4, 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)
  • K864183 — OPHTHALMIC SURGICAL INSTRUMENTS (November 28, 1986)
  • K864266 — OPHTHALMIC KNIFE & FORCEPS (November 28, 1986)
  • K864071 — FAULKNER FORCEPS (November 13, 1986)

FDA data resources