Nasal Septal Splint
FDA 510(k) K921195 · Smith & Nephew Richards, Inc.
510(k) numberK921195
Submission
- Device name
- Nasal Septal Splint
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- March 12, 1992
- Decision date
- July 23, 1992
- 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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| K141816 | HemoporeLYA · Traditional | Polyganics B.V., | 10/23/2014SE |
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| K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentJWH · Traditional | 12/05/1996SN |
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| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
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Questions and answers
When was Nasal Septal Splint cleared by the FDA?
Nasal Septal Splint (K921195) received a 510(k) decision of Substantially Equivalent on July 23, 1992, 133 days after the submission was received.
What is the product code of K921195?
The FDA product code is LYA – Splint, Intranasal Septal, a Class I (low risk) device regulated under 21 CFR 874.4780.