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510(k) K851800

69-100 TO 69-114 VARIOUS CUTICLE SCISSORS by Artiberia — Product Code HRR

K851800 is an FDA 510(k) premarket notification submitted by Artiberia for the device "69-100 TO 69-114 VARIOUS CUTICLE SCISSORS". The FDA issued a decision of Substantially Equivalent on June 20, 1985. The device falls under product code HRR (Scissors, Orthopedic, Surgical), a Class I device regulated under 21 CFR 888.4540. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Orthopedic, Surgical
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Artiberia

  • K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (August 29, 1985)
  • K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (July 9, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851721 — 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (July 2, 1985)
  • K851723 — 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (July 2, 1985)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (July 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (July 2, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (July 2, 1985)

Other clearances for product code HRR

  • K890212 — MICROSURGICAL SCISSORS (January 27, 1989)
  • K890261 — TRIGEMINAL SCISSORS (January 27, 1989)
  • K890225 — SURGICAL SCISSORS (January 27, 1989)
  • K873501 — SCISSOR, LEFT (November 2, 1987)
  • K873502 — SCISSOR, RIGHT (November 2, 1987)
  • K842953 — ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL (August 21, 1984)
  • K800721 — GENERAL UTILITY SURG. SCISSORS #460180- (May 8, 1980)

FDA data resources