The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Ed-3410, Video Duodenoscope.
| Device ID | K963056 |
| 510k Number | K963056 |
| Device Name: | ED-3410, VIDEO DUODENOSCOPE |
| Classification | Duodenoscope 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 | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-06 |
| Decision Date | 1996-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333073030 | K963056 | 000 |
| 04961333071142 | K963056 | 000 |
| 04961333070459 | K963056 | 000 |
| 04961333070442 | K963056 | 000 |
| 04961333084470 | K963056 | 000 |
| 04961333084456 | K963056 | 000 |