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510(k) K812918

PILLING K KNIFE by Narco Scientific — Product Code HNN

K812918 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PILLING K KNIFE". The FDA issued a decision of Substantially Equivalent on Nov 6, 1981. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Narco Scientific has 29 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 6, 1981
Date Received
Oct 19, 1981
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 Narco Scientific

  • K830338 — NARCOTRACE 80 (Dec 22, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (Oct 14, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (Oct 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (Sep 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (Sep 12, 1983)
  • K831460 — AS 30/TCP MODULE (Jul 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (Jun 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (Apr 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (Apr 8, 1983)

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 K812918. Report a data issue: hello@regdatalab.com.