The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Ureterorenofiberscope, Model Fur-10p.
| Device ID | K914106 |
| 510k Number | K914106 |
| Device Name: | PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Lorraine Schwartz |
| Correspondent | Lorraine Schwartz PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-13 |
| Decision Date | 1992-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333227839 | K914106 | 000 |
| 04961333171415 | K914106 | 000 |
| 04961333071449 | K914106 | 000 |