The following data is part of a premarket notification filed by Cox-uphuff Intl. with the FDA for Cos-uphoff Int'l Ds-5 Drainage System.
Device ID | K802214 |
510k Number | K802214 |
Device Name: | COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | COX-UPHUFF INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-12 |
Decision Date | 1980-10-23 |