The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for B-f200 Bronchoscope With Bss-f21 Endosheath System.
| Device ID | K021344 |
| 510k Number | K021344 |
| Device Name: | B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-29 |
| Decision Date | 2002-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485001544 | K021344 | 000 |