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 |