510(k) K884889
K884889 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Protek, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1989
- Date Received
- November 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type