The following data is part of a premarket notification filed by Pollux Endoscopy, Inc. with the FDA for Pollux Oa/pollux 30a/pollux 70a.
| Device ID | K953484 |
| 510k Number | K953484 |
| Device Name: | POLLUX OA/POLLUX 30A/POLLUX 70A |
| Classification | Arthroscope |
| Applicant | POLLUX ENDOSCOPY, INC. 4696 N.W. 103RD AVE. Sunrise, FL 33351 |
| Contact | Precious Resch |
| Correspondent | Precious Resch POLLUX ENDOSCOPY, INC. 4696 N.W. 103RD AVE. Sunrise, FL 33351 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-25 |
| Decision Date | 1995-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190660196264 | K953484 | 000 |
| 00190660196257 | K953484 | 000 |
| 00190660196240 | K953484 | 000 |
| 00190660196233 | K953484 | 000 |