510(k) K841410
K841410 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "BUSH NECK W/TAP". The FDA issued a decision of Substantially Equivalent on April 18, 1984. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1984
- Date Received
- April 5, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Cardiac, External
- Device Class
- Class II
- Regulation Number
- 870.5200
- Review Panel
- CV
- Submission Type