510(k) K952543
K952543 is an FDA 510(k) premarket notification submitted by Neoligaments, Ltd. for the device "GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on June 22, 1995. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Neoligaments, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1995
- Date Received
- May 18, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type