The following data is part of a premarket notification filed by Alza Corp. with the FDA for Ar/mde Infusor Model 60/2 Infusion Pump.
Device ID | K791720 |
510k Number | K791720 |
Device Name: | AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP |
Classification | Pump, Infusion |
Applicant | ALZA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-30 |
Decision Date | 1979-11-05 |