The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Cystoscope.
Device ID | K993689 |
510k Number | K993689 |
Device Name: | AED CYSTOSCOPE |
Classification | Cystoscope And Accessories, Flexible/rigid |
Applicant | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles, CA 90064 |
Contact | Gayle M Butler |
Correspondent | Gayle M Butler NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 10801 NATIONAL BLVD., #603 Los Angeles, CA 90064 |
Product Code | FAJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-01 |
Decision Date | 1999-12-15 |