510(k) K200387
K200387 is an FDA 510(k) premarket notification submitted by Ace Medical for the device "Ace Medical Surgical Instruments". The FDA issued a decision of Substantially Equivalent on July 21, 2020. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Ace Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2020
- Date Received
- February 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type