The following data is part of a premarket notification filed by Jieying Laboratory Inc. with the FDA for Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (pzd) Pipette; Assisted Ha.
| Device ID | K102480 |
| 510k Number | K102480 |
| Device Name: | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | JIEYING LABORATORY INC. 9722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland JIEYING LABORATORY INC. 9722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2011-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540268000068 | K102480 | 000 |
| 07540268000020 | K102480 | 000 |
| 07540268000044 | K102480 | 000 |