The following data is part of a premarket notification filed by Research Instruments Limited with the FDA for Ez-tip Singles, Ez-tip Vial Of 20, Ez-grip.
| Device ID | K161275 |
| 510k Number | K161275 |
| Device Name: | EZ-Tip Singles, EZ-Tip Vial Of 20, EZ-Grip |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
| Contact | Wendy Hassan |
| Correspondent | Wendy Hassan RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-06 |
| Decision Date | 2017-01-23 |
| Summary: | summary |