The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fcp-9p, Fiber Choledochoscope.
| Device ID | K953286 |
| 510k Number | K953286 |
| Device Name: | FCP-9P, FIBER CHOLEDOCHOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-13 |
| Decision Date | 1995-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232727 | K953286 | 000 |
| 04961333223923 | K953286 | 000 |
| 04961333063734 | K953286 | 000 |
| 04961333171255 | K953286 | 000 |
| 04961333073016 | K953286 | 000 |