The following data is part of a premarket notification filed by Applied Medical with the FDA for Surgical Trocar.
| Device ID | K911462 |
| 510k Number | K911462 |
| Device Name: | SURGICAL TROCAR |
| Classification | Trocar |
| Applicant | APPLIED MEDICAL 93 NASHAWAY RD. Bolton, MA 01740 |
| Contact | Robert W Schaefer |
| Correspondent | Robert W Schaefer APPLIED MEDICAL 93 NASHAWAY RD. Bolton, MA 01740 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-04-22 |