The following data is part of a premarket notification filed by Linde Div. Union Carbide Corp. with the FDA for Medigas Suction/drainage Equipment.
Device ID | K821841 |
510k Number | K821841 |
Device Name: | MEDIGAS SUCTION/DRAINAGE EQUIPMENT |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | LINDE DIV. UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-22 |
Decision Date | 1982-07-02 |