The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision Sciences Flexible Ent Scope.
| Device ID | K100125 |
| 510k Number | K100125 |
| Device Name: | VISION SCIENCES FLEXIBLE ENT SCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Contact | Lillian Quintero |
| Correspondent | Lillian Quintero VISION-SCIENCES, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485000318 | K100125 | 000 |