The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Mammary Sizer.
| Device ID | K961356 |
| 510k Number | K961356 |
| Device Name: | MAMMARY SIZER |
| Classification | Sizer, Mammary, Breast Implant Volume |
| Applicant | GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. Palo Alto, CA 94304 |
| Contact | Theresa M Nararoff |
| Correspondent | Theresa M Nararoff GENERAL SURGICAL INNOVATIONS 3172A PORTER DR. Palo Alto, CA 94304 |
| Product Code | MRD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-09-23 |
| Summary: | summary |