HADGEL, 4 GRAM/SYRINGE— 510(k) K011544

Substantially Equivalent

Seikagaku Corp.

FDA 510(k) clearance K011544 for HADGEL, 4 GRAM/SYRINGE, Substantially Equivalent on 2001-08-15. Applicant: Seikagaku Corp.. Device class: 1.

Clearance details

Applicant: Seikagaku Corp.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2001-05-18
Decision date: 2001-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kitty Hawk, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.