The following data is part of a premarket notification filed by Reed Products, Inc. with the FDA for First Response Emerg. Eye Injuries.
Device ID | K841900 |
510k Number | K841900 |
Device Name: | FIRST RESPONSE EMERG. EYE INJURIES |
Classification | First Aid Kit With Drug |
Applicant | REED PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-07 |
Decision Date | 1984-07-23 |