FDA 510(k), K884889, MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
FDA 510(k), K884889, MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
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510(K) Number: K884889
Device Name: MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
Manufacturer: PROTEK, INC.
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 11/22/1988
Decision Date: 02/27/1989
Regulation Medical Specialty: Orthopedic
Device Name: MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
Manufacturer: PROTEK, INC.
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 11/22/1988
Decision Date: 02/27/1989
Regulation Medical Specialty: Orthopedic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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