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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060170185414 | K161275 | 000 |
| 05060170181591 | K161275 | 000 |
| 05060170181577 | K161275 | 000 |
| 05060170181560 | K161275 | 000 |
| 05060170181553 | K161275 | 000 |
| 05060170181546 | K161275 | 000 |
| 05060170181539 | K161275 | 000 |
| 05060170181522 | K161275 | 000 |
| 05060170181515 | K161275 | 000 |
| 05060170181508 | K161275 | 000 |
| 05060170181492 | K161275 | 000 |
| 05060170181485 | K161275 | 000 |
| 05060170181478 | K161275 | 000 |
| 05060170181461 | K161275 | 000 |
| 05060170181607 | K161275 | 000 |
| 05060170181614 | K161275 | 000 |
| 05060170181690 | K161275 | 000 |
| 05060170185407 | K161275 | 000 |
| 05060170185391 | K161275 | 000 |
| 05060170185384 | K161275 | 000 |
| 05060170185377 | K161275 | 000 |
| 05060170185360 | K161275 | 000 |
| 05060170185353 | K161275 | 000 |
| 05060170185346 | K161275 | 000 |
| 05060170185339 | K161275 | 000 |
| 05060170185322 | K161275 | 000 |
| 05060170183809 | K161275 | 000 |
| 05060170183441 | K161275 | 000 |
| 05060170183380 | K161275 | 000 |
| 05060170183328 | K161275 | 000 |
| 05060170181454 | K161275 | 000 |