The following data is part of a premarket notification filed by Endovations with the FDA for 5mm Microscissors.
| Device ID | K913870 |
| 510k Number | K913870 |
| Device Name: | 5MM MICROSCISSORS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
| Contact | Jane E Predix |
| Correspondent | Jane E Predix ENDOVATIONS ROSSMOYNE INDUSTRIAL PARK 5020 RITTER ROAD, SUITE 211 Mechanicsburg, PA 17055 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1991-09-16 |