The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Vacuum Relief Valve.
Device ID | K760894 |
510k Number | K760894 |
Device Name: | VACUUM RELIEF VALVE |
Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
Applicant | DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWD |
CFR Regulation Number | 870.4430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-26 |
Decision Date | 1976-12-09 |