510(k) K885100
K885100 is an FDA 510(k) premarket notification submitted by Mcconnell Orthopedic for the device "MCCONNELL REAMER GUIDE". The FDA issued a decision of Substantially Equivalent on January 13, 1989. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Mcconnell Orthopedic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1989
- Date Received
- December 12, 1988
- 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