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510(k) K822151

SURGICAL INSTRUMENTS REPRESENT. 4 CLASS by Robert I. Chien & Assoc., Inc. — Product Code HNF

K822151 is an FDA 510(k) premarket notification submitted by Robert I. Chien & Assoc., Inc. for the device "SURGICAL INSTRUMENTS REPRESENT. 4 CLASS". The FDA issued a decision of Substantially Equivalent on August 19, 1982. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Robert I. Chien & Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1982
Date Received
July 22, 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 Robert I. Chien & Assoc., Inc.

  • K811632 — UNSTERILIZED LAPAROTOMY SPONGES (CHINA) (September 11, 1981)
  • K811631 — THERMOMETER (MADE IN CHINA) (July 20, 1981)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

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)
  • K821286 — IRIS SCISSORS STRAIGHT 4 1/2 (May 28, 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