The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Hemosleeve, Model 4.0mm, 5.5mm.
| Device ID | K984018 |
| 510k Number | K984018 |
| Device Name: | HEMOSLEEVE, MODEL 4.0MM, 5.5MM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-03-15 |
| Summary: | summary |