The following data is part of a premarket notification filed by Berkeley Medevices with the FDA for Medevices Aspiration Hose.
Device ID | K823006 |
510k Number | K823006 |
Device Name: | MEDEVICES ASPIRATION HOSE |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | BERKELEY MEDEVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-12 |
Decision Date | 1982-11-04 |