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510(k) K881049

BRADBURY INTRAOCULAR RETINAL KIT CAT #200 by Microline Pentax, Inc. — Product Code HNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1988
Date Received
March 11, 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 by Microline Pentax, Inc.

  • K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIP (January 8, 2002)
  • K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS (October 21, 1998)
  • K981389 — DISPOSABLE RE-NEW FORCEPS (May 29, 1998)
  • K981188 — ELECTROSURGICAL CAUTERY PROBES (May 20, 1998)
  • K980758 — 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS (March 27, 1998)
  • K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS (January 22, 1998)
  • K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORS (March 28, 1997)
  • K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS (August 9, 1996)
  • K932648 — QUICK SWITCH LAPAROSCOPIC INSTRUMENTS (October 12, 1993)
  • K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (April 4, 1990)

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)
  • 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)