The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Mid-500.
Device ID | K940117 |
510k Number | K940117 |
Device Name: | MID-500 |
Classification | Pump, Infusion, Elastomeric |
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 | MEB |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-10 |
Decision Date | 1994-06-10 |