The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Saphlift.
| Device ID | K990062 |
| 510k Number | K990062 |
| Device Name: | SAPHLIFT |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-08 |
| Decision Date | 1999-03-30 |
| Summary: | summary |