510(k) K790307
K790307 is an FDA 510(k) premarket notification submitted by 3M Company for the device "FLEXIBLE REAMER, GUIDE WIRE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1979. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1979
- Date Received
- February 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reamer
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type