510(k) K003169
K003169 is an FDA 510(k) premarket notification submitted by Std Mfg., Inc. for the device "VASCULAR CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on December 8, 2000. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Std Mfg., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2000
- Date Received
- October 10, 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