The following data is part of a premarket notification filed by Pollux Endoscopy, Inc. with the FDA for Cystoscope 0/15/30/70 Degrees.
| Device ID | K960872 |
| 510k Number | K960872 |
| Device Name: | CYSTOSCOPE 0/15/30/70 DEGREES |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | POLLUX ENDOSCOPY, INC. 4696 N.W. 103RD AVE. Sunrise, FL 33351 |
| Contact | Precious J Resch |
| Correspondent | Precious J Resch POLLUX ENDOSCOPY, INC. 4696 N.W. 103RD AVE. Sunrise, FL 33351 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-05-07 |
| Summary: | summary |