The following data is part of a premarket notification filed by Metrex Research Corp. with the FDA for Coldcide-10.
| Device ID | K950516 |
| 510k Number | K950516 |
| Device Name: | COLDCIDE-10 |
| Classification | Disinfectant, Medical Devices |
| Applicant | METREX RESEARCH CORP. P.O. BOX 646 10270 SOUTH PROGRESS WAY Parker, CO 80134 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe METREX RESEARCH CORP. P.O. BOX 646 10270 SOUTH PROGRESS WAY Parker, CO 80134 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-03-22 |