The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Poly Insert 20 Degree.
Device ID | K920929 |
510k Number | K920929 |
Device Name: | POLY INSERT 20 DEGREE |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Kim Tompkins |
Correspondent | Kim Tompkins DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | JDL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-28 |
Decision Date | 1993-05-05 |