510(k) K944054
K944054 is an FDA 510(k) premarket notification submitted by Arent Fox for the device "POWDER FREE SURGEON'S GLOVE". The FDA issued a decision of Substantially Equivalent on November 17, 1994. The device falls under product code KGD (Scissors For Cystoscope), a Class II device regulated under 21 CFR 876.1500. Arent Fox has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1994
- Date Received
- August 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors For Cystoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type