The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Browne Mvi Steam Indicator.
| Device ID | K971369 |
| 510k Number | K971369 |
| Device Name: | BROWNE MVI STEAM INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1998-01-29 |
| Summary: | summary |