The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Flexible Hysteroscope With Endosheath System.
| Device ID | K071127 |
| 510k Number | K071127 |
| Device Name: | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2007-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485003159 | K071127 | 000 |
| 00874485003142 | K071127 | 000 |