The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Browne Tst Single Use Bowie Dick/integrator Test Pack.
| Device ID | K002741 |
| 510k Number | K002741 |
| Device Name: | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK |
| Classification | Indicator, Physical/chemical 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 | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-01 |
| Decision Date | 2002-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995084573 | K002741 | 000 |
| 10724995218536 | K002741 | 000 |