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510(k) K813187

PILLING LACRIMAL INTUBATION SYSTEM by Narco Scientific — Product Code HNL

K813187 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PILLING LACRIMAL INTUBATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Narco Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
November 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Narco Scientific

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

Other clearances for product code HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (October 5, 1984)
  • K840861 — TSE-ANDERSON MODIFIED LACRIMAL GROOV (May 9, 1984)
  • K833671 — STERILE OIL AND GUIDEWIRE (January 10, 1984)
  • K831901 — LACIMAL INTUBATION SETS (July 12, 1983)
  • K812255 — ETHICON LACRIMAL STENT (August 20, 1981)
  • K802845 — CONCEPT CANALICULUS INTUBATION SET (December 17, 1980)
  • K801232 — JACKSON LACRIMAL INTUBATION SET (June 17, 1980)
  • K800089 — CRAWFORD LACRIMAL INTUBATION SET (March 3, 1980)
  • K770194 — NASO-LACRIMAL DUCT INSERT (February 14, 1977)

FDA data resources