The following data is part of a premarket notification filed by Huntington Laboratories, Inc. with the FDA for Formulation Hws-64 Epa Reg. No. 47371-131.
| Device ID | K953011 |
| 510k Number | K953011 |
| Device Name: | FORMULATION HWS-64 EPA REG. NO. 47371-131 |
| Classification | Disinfectant, Medical Devices |
| Applicant | HUNTINGTON LABORATORIES, INC. 970 EAST TIPTON ST. Huntington, IN 46750 |
| Contact | Sally Hayes |
| Correspondent | Sally Hayes HUNTINGTON LABORATORIES, INC. 970 EAST TIPTON ST. Huntington, IN 46750 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1995-08-11 |