The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Verify Self-contained Biological Indicator.
| Device ID | K051056 |
| 510k Number | K051056 |
| Device Name: | VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J M. Nolte |
| Correspondent | Cynthia J M. Nolte ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-10-20 |
| Summary: | summary |