SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING

Nasopharyngoscope (flexible Or Rigid)

VISION-SCIENCES, INC.

The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Slide-on Endosheath System For Sensory Testing.

Pre-market Notification Details

• Device ID: K031790
• 510k Number: K031790
• Device Name: SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
• 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-10
• Decision Date: 2003-07-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994657828	K031790	000
20613994394648	K031790	000
20613994394556	K031790	000
20613994394549	K031790	000
20613994394532	K031790	000
20613994394525	K031790	000
20613994394518	K031790	000
20613994394501	K031790	000