The following data is part of a premarket notification filed by Questech Intl., Inc. with the FDA for Clensatron Automatic Contact Lens Cleaner.
| Device ID | K884414 |
| 510k Number | K884414 |
| Device Name: | CLENSATRON AUTOMATIC CONTACT LENS CLEANER |
| Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | QUESTECH INTL., INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf QUESTECH INTL., INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Product Code | LYL |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1988-12-29 |