V-DENUPET
Microtools, Assisted Reproduction (pipettes)
Vitromed GmbH
The following data is part of a premarket notification filed by Vitromed Gmbh with the FDA for V-denupet.
Pre-market Notification Details
| Device ID | K192146 |
| 510k Number | K192146 |
| Device Name: | V-DENUPET |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | Vitromed GmbH Hans-Knöll-Str. 6 Jena, DE 07745 |
| Contact | Deepesh Changat |
| Correspondent | Robyn Scopis Regulatory Specialists, Inc. 628 El Mirador Drive Fullerton, CA 92835 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-08 |
| Decision Date | 2020-01-28 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260531791525 | K192146 | 000 |
| 04260531791518 | K192146 | 000 |
| 04260531791501 | K192146 | 000 |
| 04260531791495 | K192146 | 000 |
| 04260531791488 | K192146 | 000 |
| 04260531791464 | K192146 | 000 |
| 04260531791457 | K192146 | 000 |
| 04260531791440 | K192146 | 000 |
| 04260531791433 | K192146 | 000 |
Trademark Results [V-DENUPET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 V-DENUPET 79278503 not registered Live/Pending |
VITROMED GmbH 2020-01-07 |
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