The following data is part of a premarket notification filed by Surgrx, Inc. with the FDA for Modification To: Enseal Ptc Tissue Sealing Device.
| Device ID | K071728 |
| 510k Number | K071728 |
| Device Name: | MODIFICATION TO: 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 | 2007-06-25 |
| Decision Date | 2007-07-13 |
| Summary: | summary |