510(k) K871073
K871073 is an FDA 510(k) premarket notification submitted by Omega Silicone, Inc. for the device "OMEGA BIVALVE NASAL SPLINTS". The FDA issued a decision of Substantially Equivalent on May 11, 1987. The device falls under product code FYI (Appliance, Facial Fracture, External), a Class I device regulated under 21 CFR 878.3250. Omega Silicone, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1987
- Date Received
- March 18, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Facial Fracture, External
- Device Class
- Class I
- Regulation Number
- 878.3250
- Review Panel
- SU
- Submission Type