The following data is part of a premarket notification filed by Research Instruments Ltd. with the FDA for Biopsy Pipettes.
Device ID | K133257 |
510k Number | K133257 |
Device Name: | BIOPSY PIPETTES |
Classification | Microtools, Assisted Reproduction (pipettes) |
Applicant | RESEARCH INSTRUMENTS LTD. BICKLAND WATER INDUSTRIAL PARK FALMOUTH Cornwall, GB Tr 11 4ta |
Contact | David Lansdowne |
Correspondent | David Lansdowne RESEARCH INSTRUMENTS LTD. BICKLAND WATER INDUSTRIAL PARK FALMOUTH Cornwall, GB Tr 11 4ta |
Product Code | MQH |
CFR Regulation Number | 884.6130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-23 |
Decision Date | 2014-05-16 |
Summary: | summary |