The following data is part of a premarket notification filed by Medical Products Laboratories, Inc. with the FDA for Pre-klene Enamel Cleaner.
| Device ID | K844572 |
| 510k Number | K844572 |
| Device Name: | PRE-KLENE ENAMEL CLEANER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | MEDICAL PRODUCTS LABORATORIES, INC. 9990 GLOBAL RD. Philadelphia, PA 19115 |
| Contact | Harold Stone |
| Correspondent | Harold Stone MEDICAL PRODUCTS LABORATORIES, INC. 9990 GLOBAL RD. Philadelphia, PA 19115 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-01-18 |