510(k) K893480
K893480 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "BYRD EXTRACTOR SET". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code GCC (Dilator, Catheter), a Class I device regulated under 21 CFR 878.4200. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1989
- Date Received
- May 4, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Catheter
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type