The following data is part of a premarket notification filed by Graseby Medical Ltd. with the FDA for 3400 Infusion Pump.
Device ID | K931318 |
510k Number | K931318 |
Device Name: | 3400 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
Contact | Weyman |
Correspondent | Weyman GRASEBY MEDICAL LTD. COLONIAL WAY Watford, Herts., GB Wd24 4lg |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-16 |
Decision Date | 1994-12-09 |