The following data is part of a premarket notification filed by Healthpoint, Ltd. with the FDA for Aldahol Iii High-level Disinfectant.
| Device ID | K041360 |
| 510k Number | K041360 |
| Device Name: | ALDAHOL III HIGH-LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | HEALTHPOINT, LTD. 1107-C S. AIRPORT CIRCLE Euless (dallas), TX 76040 |
| Contact | Norm Miner, Phd |
| Correspondent | Norm Miner, Phd HEALTHPOINT, LTD. 1107-C S. AIRPORT CIRCLE Euless (dallas), TX 76040 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-21 |
| Decision Date | 2005-05-05 |
| Summary: | summary |