The following data is part of a premarket notification filed by Ellis Pharmaceutical Consulting, Inc. with the FDA for Sterets Injection Swab.
| Device ID | K852235 |
| 510k Number | K852235 |
| Device Name: | STERETS INJECTION SWAB |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | ELLIS PHARMACEUTICAL CONSULTING, INC. 913 STATE RD. Princeton, NJ 08540 -1484 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis ELLIS PHARMACEUTICAL CONSULTING, INC. 913 STATE RD. Princeton, NJ 08540 -1484 |
| Product Code | LKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-22 |
| Decision Date | 1985-06-07 |