SEPRAGEL SINUS— 510(k) K012532

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K012532 for SEPRAGEL SINUS, Substantially Equivalent on 2001-10-30. Applicant: Genzyme Corp.. Device class: 1.

Clearance details

Applicant: Genzyme Corp.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2001-08-06
Decision date: 2001-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, 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.