Sepragel Sinus
FDA 510(k) K012532 · Genzyme Corp.
510(k) numberK012532
Submission
- Device name
- Sepragel Sinus
- Applicant
- Genzyme Corp.
Ridgefield, NJ, US - Received
- August 6, 2001
- Decision date
- October 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYA – Splint, Intranasal Septal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4780
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Sepragel Sinus cleared by the FDA?
Sepragel Sinus (K012532) received a 510(k) decision of Substantially Equivalent on October 30, 2001, 85 days after the submission was received.
What is the product code of K012532?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.