510(k) K800800
K800800 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "PATELLAR COMPONENT FOR LUBINUS PATELLAR". The FDA issued a decision of Substantially Equivalent on April 21, 1980. The device falls under product code HTG (Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented), a Class II device regulated under 21 CFR 888.3580. Waldemar Link GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1980
- Date Received
- April 10, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3580
- Review Panel
- OR
- Submission Type