Silimed Nasal Retainer
FDA 510(k) K980221 · Silimed, LLC
510(k) numberK980221
Submission
- Device name
- Silimed Nasal Retainer
- Applicant
- Silimed, LLC
Crofton, MD, US - Received
- January 22, 1998
- Decision date
- April 2, 1998
- 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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| K172179 | Chitogel Endoscopic Sinus Surgery KitLYA · Traditional | Chitogel, Ltd. | 10/17/2017SE |
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| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
More from Polyganics B.V.,
| 510(k) | Device | Decision |
|---|---|---|
| K042054 | Silimed Pectoral ImplantMIB · Traditional | 02/23/2005SE |
| K981852 | Silimed Tissue ExpanderLCJ · Traditional | 08/05/1998SE |
| K974479 | Silimed Vaginal StentKXP · Traditional | 08/05/1998SE |
| K981851 | Silimed Silicone Carving BlockMIB · Traditional | 07/09/1998SE |
| K981850 | Silimed Chin ImplantsFWP · Traditional | 07/09/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | 07/09/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | 06/26/1998SE |
| K974482 | Silimed Gluteal ImplantMIB · Traditional | 02/24/1998SE |
| K974480 | Silimed Calf ImplantMIB · Traditional | 02/24/1998SE |
Questions and answers
When was Silimed Nasal Retainer cleared by the FDA?
Silimed Nasal Retainer (K980221) received a 510(k) decision of Substantially Equivalent on April 2, 1998, 70 days after the submission was received.
What is the product code of K980221?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.