510(k) K052387
K052387 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX". The FDA issued a decision of Substantially Equivalent on November 29, 2005. The device falls under product code LZB (Finger Cot), a Class I device regulated under 21 CFR 880.6250. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2005
- Date Received
- August 31, 2005
- 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