The following data is part of a premarket notification filed by Eaton Medical Corp. with the FDA for The Cleaner Accessory.
Device ID | K921882 |
510k Number | K921882 |
Device Name: | THE CLEANER ACCESSORY |
Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
Applicant | EATON MEDICAL CORP. 2288 DUNN AVE. Memphis, TN 38114 |
Contact | Bron Eaton |
Correspondent | Bron Eaton EATON MEDICAL CORP. 2288 DUNN AVE. Memphis, TN 38114 |
Product Code | LYL |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-21 |
Decision Date | 1992-08-25 |