The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Eg-3630ur, Ultrasound Video Gastroscope.
| Device ID | K021278 |
| 510k Number | K021278 |
| Device Name: | EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | ODG |
| Subsequent Product Code | FDS |
| Subsequent Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2002-09-06 |
| Summary: | summary |