The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Multiple Dose Controller.
Device ID | K914855 |
510k Number | K914855 |
Device Name: | MULTIPLE DOSE CONTROLLER |
Classification | Pump, Infusion |
Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
Contact | Ian Kennedy |
Correspondent | Ian Kennedy BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-28 |
Decision Date | 1992-01-24 |