The following data is part of a premarket notification filed by Board Of Directors, Albert Browne Ltd. with the FDA for Tst Control Integrator For Steam Autoclave.
Device ID | K902958 |
510k Number | K902958 |
Device Name: | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHANCERY HOUSE, ABBEY GATE LEICESTER Leics. Le4 Oaa, GB |
Contact | Copson |
Correspondent | Copson BOARD OF DIRECTORS, ALBERT BROWNE LTD. CHANCERY HOUSE, ABBEY GATE LEICESTER Leics. Le4 Oaa, GB |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-05 |
Decision Date | 1990-11-01 |