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510(k) K851775

19-790 TO 19-1042 DRESSING/SPONGE FORCEPS by Artiberia — Product Code KAE

K851775 is an FDA 510(k) premarket notification submitted by Artiberia for the device "19-790 TO 19-1042 DRESSING/SPONGE FORCEPS". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Ent
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
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 KAE

  • K853708 — LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE (February 14, 1986)
  • K851794 — 41-180 TO 41-246 VARIOUS NASAL FORCEPS (June 11, 1985)
  • K851795 — 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS (June 11, 1985)
  • K833608 — GOLD ALLIGATOR FORCEPS (January 11, 1984)
  • K833607 — MCGEE FORCEPS (January 3, 1984)
  • K833605 — CUPPED FORCEPS (January 3, 1984)
  • K822372 — OFFICE ECONO-FORCEPS (September 9, 1982)
  • K822369 — MICRO & MINI-MICRO ALLIGATOR FORCEPS (September 9, 1982)
  • K812895 — YARMO NASAL CARTILAGE SOFTENER (November 2, 1981)
  • K772396 — ALLIGATOR CUP FORCEPS (January 17, 1978)

FDA data resources