MammoGRIP
System, X-ray, Mammographic
Women's Imaging Solutions Enterprises LLC
The following data is part of a premarket notification filed by Women's Imaging Solutions Enterprises Llc with the FDA for Mammogrip.
Pre-market Notification Details
| Device ID | K152038 |
| 510k Number | K152038 |
| Device Name: | MammoGRIP |
| Classification | System, X-ray, Mammographic |
| Applicant | Women's Imaging Solutions Enterprises LLC 226 Wilson Drive Cresskill, NJ 07626 |
| Contact | Nancy Derobertis |
| Correspondent | Erika Huffman NAMSA 4050 Olson Memorial Highway Minneapolis, MN 55422 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-22 |
| Decision Date | 2015-12-22 |
| Summary: | summary |
Trademark Results [MammoGRIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAMMOGRIP 85472350 4863430 Live/Registered |
DeRobertis, Nancy 2011-11-14 |
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