The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Eb-1830t3, Video Bronchoscope.
| Device ID | K023376 |
| 510k Number | K023376 |
| Device Name: | EB-1830T3, VIDEO BRONCHOSCOPE |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2002-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333224562 | K023376 | 000 |
| 04961333224425 | K023376 | 000 |
| 04961333224340 | K023376 | 000 |
| 04961333073009 | K023376 | 000 |
| 04961333063819 | K023376 | 000 |