The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Verify Flash Integrator.
Device ID | K051101 |
510k Number | K051101 |
Device Name: | VERIFY FLASH INTEGRATOR |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | ALBERT BROWNE LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Cynthia J M. Nolte |
Correspondent | Cynthia J M. Nolte ALBERT BROWNE LTD. 49 PLAIN STREET 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 | 2005-04-29 |
Decision Date | 2005-12-06 |
Summary: | summary |