The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Tst Control Integrator For Steam Autoclave.
| Device ID | K965154 |
| 510k Number | K965154 |
| Device Name: | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE |
| Classification | Indicator, Sterilization |
| Applicant | ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte, Ph.d. |
| Correspondent | Cynthia J.m. Nolte, Ph.d. ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | LRT |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-09-19 |
| Summary: | summary |