The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Mammary Sizer, Mammary Prothesis Sizer.
| Device ID | K984106 |
| 510k Number | K984106 |
| Device Name: | MAMMARY SIZER, MAMMARY PROTHESIS SIZER |
| Classification | Sizer, Mammary, Breast Implant Volume |
| Applicant | SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Contact | T.jan Varner |
| Correspondent | T.jan Varner SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Product Code | MRD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-02-12 |