The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Eg-3400, Video Gastroscope.
| Device ID | K962897 |
| 510k Number | K962897 |
| Device Name: | EG-3400, VIDEO GASTROSCOPE |
| Classification | Gastroscope 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-25 |
| Decision Date | 1996-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232925 | K962897 | 000 |
| 04961333232505 | K962897 | 000 |
| 04961333232499 | K962897 | 000 |
| 04961333227686 | K962897 | 000 |
| 04961333224913 | K962897 | 000 |
| 04961333224647 | K962897 | 000 |
| 04961333224449 | K962897 | 000 |
| 04961333071357 | K962897 | 000 |