The following data is part of a premarket notification filed by Board Of Directors, Albert Browne Ltd. with the FDA for Browne Tst Single Use Bowie-dick Type Test Pack.
| Device ID | K971971 |
| 510k Number | K971971 |
| Device Name: | BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | BOARD OF DIRECTORS, ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J. M. Nolte |
| Correspondent | Cynthia J. M. Nolte BOARD OF DIRECTORS, 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 | 1997-05-29 |
| Decision Date | 1998-07-10 |
| Summary: | summary |