The following data is part of a premarket notification filed by Inter-med / Vista Dental Products with the FDA for Vista Clear.
Device ID | K193389 |
510k Number | K193389 |
Device Name: | Vista Clear |
Classification | Cord, Retraction |
Applicant | Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Contact | Alex Johnson |
Correspondent | Alex Johnson Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
Product Code | MVL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-06 |
Decision Date | 2020-03-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20304040151383 | K193389 | 000 |
10304040151478 | K193389 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISTA CLEAR 73625195 1441962 Dead/Cancelled |
MICROTEK MEDICAL, INC. 1986-10-14 |