The following data is part of a premarket notification filed by Engineering, Inc. with the FDA for Ls3000 Cannula Uterine Suction.
Device ID | K862476 |
510k Number | K862476 |
Device Name: | LS3000 CANNULA UTERINE SUCTION |
Classification | System, Abortion, Vacuum |
Applicant | ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
Contact | Robert Lash |
Correspondent | Robert Lash ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
Product Code | HHI |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-30 |
Decision Date | 1986-07-18 |