The following data is part of a premarket notification filed by Westlock Investments (usa), Inc. with the FDA for Steri-swab.
| Device ID | K912731 |
| 510k Number | K912731 |
| Device Name: | STERI-SWAB |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | WESTLOCK INVESTMENTS (USA), INC. 15924 N.E. 27TH PLACE Bellevue, WA 98008 |
| Contact | Kelvin Mariapragasam |
| Correspondent | Kelvin Mariapragasam WESTLOCK INVESTMENTS (USA), INC. 15924 N.E. 27TH PLACE Bellevue, WA 98008 |
| 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 | 1991-06-20 |
| Decision Date | 1991-10-02 |