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510(k) K821286

IRIS SCISSORS STRAIGHT 4 1/2 by Conphar, Inc. — Product Code HNF

K821286 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "IRIS SCISSORS STRAIGHT 4 1/2". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (August 10, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (June 3, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821298 — BACKHAUS CLAMP, 3 1/2 (May 28, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)

Other clearances for product code HNF

  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (April 4, 1990)
  • K873099 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (September 4, 1987)
  • K851768 — 13-550,13-560 WESCOTT SCOSSORS (EYE) (June 20, 1985)
  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)
  • K811245 — OPHTHALMIC SCISSORS (July 31, 1981)
  • K770041 — SCISSORS, STRABISMUS, 4 CURVED (January 14, 1977)
  • K770040 — SCISSORS, STRABIMUS, 4 STRAIGHT (January 14, 1977)
  • K770019 — SCISSORS, IRIS (January 12, 1977)

FDA data resources