The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Clarified Applica. For Lacey Condylar Total Knee.
Device ID | K872266 |
510k Number | K872266 |
Device Name: | CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Contact | Lipscomb, Phd |
Correspondent | Lipscomb, Phd DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-02 |
Decision Date | 1987-08-14 |