The following data is part of a premarket notification filed by Healthpoint, Ltd. with the FDA for Extended Use Aldahol High Level Disinfectant.
| Device ID | K091890 |
| 510k Number | K091890 |
| Device Name: | EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | HEALTHPOINT, LTD. 3909 HULEN ST. Fort Worth, TX 76107 |
| Contact | Amy Campbell |
| Correspondent | Amy Campbell HEALTHPOINT, LTD. 3909 HULEN ST. Fort Worth, TX 76107 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2010-03-24 |
| Summary: | summary |