The following data is part of a premarket notification filed by Berkeley Medevices with the FDA for Medevice V-80 Vacuum Pump.
Device ID | K840952 |
510k Number | K840952 |
Device Name: | MEDEVICE V-80 VACUUM PUMP |
Classification | System, Abortion, Vacuum |
Applicant | BERKELEY MEDEVICES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHI |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-05 |
Decision Date | 1984-03-30 |