510(k) K014286
K014286 is an FDA 510(k) premarket notification submitted by Onux Medical, Inc. for the device "SALUTE, MODEL 3022". The FDA issued a decision of Substantially Equivalent on March 8, 2002. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Onux Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2002
- Date Received
- December 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type