510(k) K003522
K003522 is an FDA 510(k) premarket notification submitted by Onux Medical, Inc. for the device "SALUTE". The FDA issued a decision of Substantially Equivalent on February 13, 2001. 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
- February 13, 2001
- Date Received
- November 15, 2000
- 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