510(k) K800363
K800363 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "PARKE-DAVIS TOTAL KNEE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on March 10, 1980. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1980
- Date Received
- February 20, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper
- Device Class
- Class I
- Regulation Number
- 888.4150
- Review Panel
- OR
- Submission Type