The following data is part of a premarket notification filed by Gynetics Medical Products Nv with the FDA for Echosampler.
| Device ID | K041237 |
| 510k Number | K041237 |
| Device Name: | ECHOSAMPLER |
| Classification | Aspirator, Endometrial |
| Applicant | GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | HFF |
| CFR Regulation Number | 884.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-09-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ECHOSAMPLER 78272860 not registered Dead/Abandoned |
Gynetics Medical Products N.V. 2003-07-10 |