The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Ves 1501-m.
Device ID | K982409 |
510k Number | K982409 |
Device Name: | VES 1501-M |
Classification | Camera, Television, Endoscopic, Without Audio |
Applicant | ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
Contact | John D Plumadore |
Correspondent | John D Plumadore ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
Product Code | FWF |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-10 |
Decision Date | 1998-08-21 |