The following data is part of a premarket notification filed by Sporicidin Intl. with the FDA for Modification To Sporicidin Sterilizing And Disinfecting Solution.
| Device ID | K003087 |
| 510k Number | K003087 |
| Device Name: | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION |
| Classification | Sterilant, Medical Devices |
| Applicant | SPORICIDIN INTL. 121 CONGRESSIONAL LN. Rockville, MD 20852 |
| Contact | Harold E Plank |
| Correspondent | Harold E Plank SPORICIDIN INTL. 121 CONGRESSIONAL LN. Rockville, MD 20852 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-27 |
| Decision Date | 2000-11-07 |