The following data is part of a premarket notification filed by Corpak Co. with the FDA for Enteral Solution Admin. Pump Set.
Device ID | K830965 |
510k Number | K830965 |
Device Name: | ENTERAL SOLUTION ADMIN. PUMP SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-28 |
Decision Date | 1983-04-18 |