The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Sterile 5 In 1 Connectors.
Device ID | K830835 |
510k Number | K830835 |
Device Name: | STERILE 5 IN 1 CONNECTORS |
Classification | Tubing, Noninvasive |
Applicant | ABCO DEALERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-16 |
Decision Date | 1983-04-06 |