510(k) K992539
K992539 is an FDA 510(k) premarket notification submitted by Digit-Pro for the device "PERCUGUARD". The FDA issued a decision of Substantially Equivalent on February 18, 2000. The device falls under product code LZB (Finger Cot), a Class I device regulated under 21 CFR 880.6250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2000
- Date Received
- July 30, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Finger Cot
- Device Class
- Class I
- Regulation Number
- 880.6250
- Review Panel
- HO
- Submission Type