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510(k) K851790

37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN by Artiberia — Product Code HNN

K851790 is an FDA 510(k) premarket notification submitted by Artiberia for the device "37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Artiberia has 78 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
Apr 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Knife, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type
510(k) Exempt

Other clearances by Artiberia

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

Other clearances for product code HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (Dec 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (Aug 22, 1988)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (Apr 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (Dec 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (Dec 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (Sep 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (Apr 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (Dec 15, 1986)

FDA data resources

Source: FDA 510(k) database entry for K851790. Report a data issue: hello@regdatalab.com.