The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Eye Tray.
Device ID | K940239 |
510k Number | K940239 |
Device Name: | EYE TRAY |
Classification | Tray, Surgical |
Applicant | CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
Contact | Steve B Johnston |
Correspondent | Steve B Johnston CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats, TN 37686 |
Product Code | LRP |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-19 |
Decision Date | 1994-06-28 |