The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Vtr 300 Enternal Pump.
Device ID | K832167 |
510k Number | K832167 |
Device Name: | CORPAK VTR 300 ENTERNAL PUMP |
Classification | Pump, Infusion |
Applicant | CORPAK CO. 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 | 1983-07-05 |
Decision Date | 1983-08-16 |