The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Albert Browne Ltd. Verify Steam And Eo Load Record Card.
Device ID | K061738 |
510k Number | K061738 |
Device Name: | ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD |
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 | 2006-06-20 |
Decision Date | 2006-08-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10724995091122 | K061738 | 000 |
10724995096714 | K061738 | 000 |
00724995172237 | K061738 | 000 |