The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Thoracoscopic Access System.
| Device ID | K953121 |
| 510k Number | K953121 |
| Device Name: | MICROSURGE THORACOSCOPIC ACCESS SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
| Contact | Richard Lariviere |
| Correspondent | Richard Lariviere MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-05 |
| Decision Date | 1995-09-29 |