The following data is part of a premarket notification filed by Dideco with the FDA for Dideco Vacuum Pump.
Device ID | K936220 |
510k Number | K936220 |
Device Name: | DIDECO VACUUM PUMP |
Classification | Apparatus, Autotransfusion |
Applicant | DIDECO VIA STATALE 12 NORD,86,41037 Mirandola, Italy, IT |
Contact | Rosina Robinson, R.n |
Correspondent | Rosina Robinson, R.n DIDECO VIA STATALE 12 NORD,86,41037 Mirandola, Italy, IT |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-28 |
Decision Date | 1995-01-27 |