The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Flow Controlling Extension Set.
| Device ID | K935236 |
| 510k Number | K935236 |
| Device Name: | FLOW CONTROLLING EXTENSION SET |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Contact | George T Walker |
| Correspondent | George T Walker BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-02-24 |