The following data is part of a premarket notification filed by Gulfstream Medical with the FDA for Diacide Hd Disinfecting Solution.
| Device ID | K944037 |
| 510k Number | K944037 |
| Device Name: | DIACIDE HD DISINFECTING SOLUTION |
| Classification | Disinfectant, Medical Devices |
| Applicant | GULFSTREAM MEDICAL 550 PLEASANT ST. Winthrop, MA 02152 |
| Contact | Adolph E D'amico |
| Correspondent | Adolph E D'amico GULFSTREAM MEDICAL 550 PLEASANT ST. Winthrop, MA 02152 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-18 |
| Decision Date | 1995-03-22 |