The following data is part of a premarket notification filed by Maxol Limited L.c. with the FDA for Maxol Image Ii Patient Matched Breast Prosthesis.
| Device ID | K951324 |
| 510k Number | K951324 |
| Device Name: | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS |
| Classification | Prosthesis, Breast, External, Used With Adhesive |
| Applicant | MAXOL LIMITED L.C. 10006 WEST 97 TERRACE Overland Park, KS 66212 |
| Contact | Mark Schanze |
| Correspondent | Mark Schanze MAXOL LIMITED L.C. 10006 WEST 97 TERRACE Overland Park, KS 66212 |
| Product Code | KCZ |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-23 |
| Decision Date | 1995-05-26 |