510(k) K830263
K830263 is an FDA 510(k) premarket notification submitted by Ritmed, Inc. for the device "FLORET NASAL TAMPON". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Ritmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type