The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision Sciences Endosheath System.
| Device ID | K012543 |
| 510k Number | K012543 |
| Device Name: | VISION SCIENCES ENDOSHEATH SYSTEM |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineu |
| Correspondent | Pamela Papineu VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2002-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000037868 | K012543 | 000 |
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| 20613994657804 | K012543 | 000 |