The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Browne Cidex Opa Indicator.
| Device ID | K991709 |
| 510k Number | K991709 |
| Device Name: | BROWNE CIDEX OPA INDICATOR |
| 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 | 1999-05-19 |
| Decision Date | 1999-10-08 |
| Summary: | summary |