510(k) K993544
K993544 is an FDA 510(k) premarket notification submitted by Advanced Surgical Concepts (Asc) for the device "SPACE-OR RETRACTOR". The FDA issued a decision of Substantially Equivalent on December 22, 1999. The device falls under product code FFO (Retractor, Self-Retaining), a Class I device regulated under 21 CFR 876.4730. Advanced Surgical Concepts (Asc) has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1999
- Date Received
- October 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Self-Retaining
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type