The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Browne Packaging And Label Steam Process Indicator.
Device ID | K992767 |
510k Number | K992767 |
Device Name: | BROWNE PACKAGING AND LABEL STEAM PROCESS 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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-17 |
Decision Date | 2000-01-10 |
Summary: | summary |