510(k) K872502
K872502 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "M.W.P. WRIST PROSTHESIS". The FDA issued a decision of Substantially Equivalent on July 23, 1987. The device falls under product code KWM (Prosthesis, Wrist, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Protek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1987
- Date Received
- June 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type