The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Disposable Endosheath For E-f100 Flexible Nasopharyngoscope.
Device ID | K961591 |
510k Number | K961591 |
Device Name: | DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
Contact | Pamela L Papineau |
Correspondent | Pamela L Papineau VISION-SCIENCES, INC. 6 STRATHMORE RD. Natick, MA 01760 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-24 |
Decision Date | 1996-07-02 |
Summary: | summary |