The following data is part of a premarket notification filed by Urohealth Systems, Inc. with the FDA for Modification To Reflex Aec Linear Stapler/cutter.
| Device ID | K980617 |
| 510k Number | K980617 |
| Device Name: | MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER |
| Classification | Staple, Implantable |
| Applicant | UROHEALTH SYSTEMS, INC. 8850 M-89 Richland, MI 49083 |
| Contact | Julie Powell |
| Correspondent | Julie Powell UROHEALTH SYSTEMS, INC. 8850 M-89 Richland, MI 49083 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-23 |
| Decision Date | 1998-04-09 |
| Summary: | summary |