The following data is part of a premarket notification filed by Optus, Inc. with the FDA for Optus Thoracoscopes.
| Device ID | K945263 |
| 510k Number | K945263 |
| Device Name: | OPTUS THORACOSCOPES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1994-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059082032351 | K945263 | 000 |
| 04059082007809 | K945263 | 000 |
| 04059082007830 | K945263 | 000 |
| 04059082013138 | K945263 | 000 |
| 04059082013152 | K945263 | 000 |
| 04059082013169 | K945263 | 000 |
| 04059082013176 | K945263 | 000 |
| 04059082013183 | K945263 | 000 |
| 04059082013237 | K945263 | 000 |
| 04059082013244 | K945263 | 000 |
| 04059082013251 | K945263 | 000 |
| 04059082013268 | K945263 | 000 |
| 04059082013275 | K945263 | 000 |
| 04059082013282 | K945263 | 000 |
| 04059082032177 | K945263 | 000 |
| 04059082032337 | K945263 | 000 |
| 04059082032344 | K945263 | 000 |
| 04059082003559 | K945263 | 000 |