The following data is part of a premarket notification filed by Surgrx, Inc. with the FDA for Enseal Ptc Tissue Sealing Device.
| Device ID | K063097 |
| 510k Number | K063097 |
| Device Name: | ENSEAL PTC TISSUE SEALING DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGRX, INC. 101 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Linda Oleson |
| Correspondent | Linda Oleson SURGRX, INC. 101 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-10 |
| Decision Date | 2006-10-18 |
| Summary: | summary |