The following data is part of a premarket notification filed by Sacks Model Makers with the FDA for Powered Eye Wash.
| Device ID | K893829 |
| 510k Number | K893829 |
| Device Name: | POWERED EYE WASH |
| Classification | Solution, Cleaning / Lubricating, Artificial Eye |
| Applicant | SACKS MODEL MAKERS 509 SKYLINE LKS. DR. Ringwood, NJ 07456 |
| Contact | Herman Sacks |
| Correspondent | Herman Sacks SACKS MODEL MAKERS 509 SKYLINE LKS. DR. Ringwood, NJ 07456 |
| Product Code | MSI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-24 |
| Decision Date | 1989-11-14 |