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FDA 510(k)

SEPRAGEL SINUS

K-Number: K012532 · 2001-10-30

ApplicantGenzyme Corp.
Decision Date2001-10-30
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SEPRAGEL SINUS is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K012532. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEPRAGEL SINUS?

SEPRAGEL SINUS is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Genzyme Corp.. The 510(k) number is K012532.

When did SEPRAGEL SINUS receive FDA 510(k) clearance?

SEPRAGEL SINUS received FDA 510(k) clearance on 2001-10-30, under 510(k) number K012532.

Who is the listed applicant for SEPRAGEL SINUS?

The FDA 510(k) record lists Genzyme Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEPRAGEL SINUS?

The FDA product code for SEPRAGEL SINUS is LYA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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