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510(k) K851786

27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF by Artiberia — Product Code LGG

K851786 is an FDA 510(k) premarket notification submitted by Artiberia for the device "27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code LGG (Instrument, Cast Application/Removal, Manual), a Class I device regulated under 21 CFR 888.5980. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cast Application/Removal, Manual
Device Class
Class I
Regulation Number
888.5980
Review Panel
OR
Submission Type

Other clearances by Artiberia

  • K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (August 29, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (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)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (July 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (July 2, 1985)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)

Other clearances for product code LGG

  • K870100 — PLASTER STAND (January 28, 1987)
  • K834384 — MODULAR EXTREMITY CASTING SUPPORT (January 30, 1984)

FDA data resources