The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Vision Sciences Model Ent-2000v Flexible Nasopharyngo-laryngoscope.
Device ID | K040984 |
510k Number | K040984 |
Device Name: | VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE |
Classification | Nasopharyngoscope (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 | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-04-15 |
Decision Date | 2004-04-27 |
Summary: | summary |