The following data is part of a premarket notification filed by Stierlen-maquet Ag with the FDA for Oper. Table For Percutan. Trans. Coronary Angio..
Device ID | K883613 |
510k Number | K883613 |
Device Name: | OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO. |
Classification | Table, Operating-room, Electrical |
Applicant | STIERLEN-MAQUET AG KEHLER STRASSE 31 7550 RASTATT West Germany, GR |
Contact | Schnelle |
Correspondent | Schnelle STIERLEN-MAQUET AG KEHLER STRASSE 31 7550 RASTATT West Germany, GR |
Product Code | GDC |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-22 |
Decision Date | 1988-09-15 |