510(k) K954915
K954915 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "FLEXIBLE INTRAMEDULLARY REAMER". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code HTO (Reamer), a Class I device regulated under 21 CFR 888.4540. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1995
- Date Received
- October 26, 1995
- 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