510(k) K882244
K882244 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code EPP (Splint, Nasal), a Class I device regulated under 21 CFR 874.5800. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1988
- Date Received
- May 31, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Nasal
- Device Class
- Class I
- Regulation Number
- 874.5800
- Review Panel
- EN
- Submission Type