510(k) K855144
K855144 is an FDA 510(k) premarket notification submitted by Dlp, Inc. for the device "TOURIQUET KIT WITH SNARE". The FDA issued a decision of Substantially Equivalent on Feb 5, 1986. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Dlp, Inc. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 5, 1986
- Date Received
- Dec 26, 1985
- 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
- 510(k) Exempt