The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Pne- Ultra-slim Upper G.i. Fiberscope Fg-23.
| Device ID | K850020 |
| 510k Number | K850020 |
| Device Name: | PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Marcia C Stark |
| Correspondent | Marcia C Stark PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-04 |
| Decision Date | 1985-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333244171 | K850020 | 000 |
| 04961333084258 | K850020 | 000 |
| 04961333083114 | K850020 | 000 |
| 04961333083091 | K850020 | 000 |
| 04961333083077 | K850020 | 000 |
| 04961333083053 | K850020 | 000 |
| 04961333082292 | K850020 | 000 |
| 04961333071203 | K850020 | 000 |
| 04961333071111 | K850020 | 000 |
| 04961333071067 | K850020 | 000 |
| 04961333063765 | K850020 | 000 |
| 04961333169047 | K850020 | 000 |
| 04961333154234 | K850020 | 000 |
| 04961333084340 | K850020 | 000 |
| 04961333118366 | K850020 | 000 |
| 04961333118380 | K850020 | 000 |
| 04961333228584 | K850020 | 000 |
| 04961333224708 | K850020 | 000 |
| 04961333224685 | K850020 | 000 |
| 04961333224661 | K850020 | 000 |
| 04961333224548 | K850020 | 000 |
| 04961333224524 | K850020 | 000 |
| 04961333224500 | K850020 | 000 |
| 04961333224487 | K850020 | 000 |
| 04961333224388 | K850020 | 000 |
| 04961333223985 | K850020 | 000 |
| 04961333148028 | K850020 | 000 |
| 04961333142750 | K850020 | 000 |
| 04961333083831 | K850020 | 000 |