The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Eye Shield.
Device ID | K843197 |
510k Number | K843197 |
Device Name: | VISITEC EYE SHIELD |
Classification | Pad, Eye |
Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Contact | Eugene H. Beckstein |
Correspondent | Eugene H. Beckstein VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Product Code | HMP |
CFR Regulation Number | 878.4440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-14 |
Decision Date | 1984-10-05 |