510(k) K931733
K931733 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "INTERMEDICS ORTHOPEDICS REAMERS". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code HTP (File), a Class I device regulated under 21 CFR 888.4540. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1994
- Date Received
- April 7, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type