The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision-sciences Ent-5000 Video Ent Scope With Endosheath Technology, Vision-sciences Dpu-5000/dpu-5050 Video Processor.
| Device ID | K102733 |
| 510k Number | K102733 |
| Device Name: | VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR |
| 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 |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HRX |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-22 |
| Decision Date | 2011-05-18 |
| Summary: | summary |