510(k) K881741
K881741 is an FDA 510(k) premarket notification submitted by Stuart-Lee, Inc. for the device "STUART LEE CLIP". The FDA issued a decision of Substantially Equivalent on June 3, 1988. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1988
- Date Received
- April 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type