The following data is part of a premarket notification filed by Forma Scientific, Inc. with the FDA for Model 3014 Suction Unit.
Device ID | K841631 |
510k Number | K841631 |
Device Name: | MODEL 3014 SUCTION UNIT |
Classification | System, Abortion, Vacuum |
Applicant | FORMA SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHI |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-20 |
Decision Date | 1984-07-03 |