The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Stopcock 2-way, 3-way & 4-way.
Device ID | K802258 |
510k Number | K802258 |
Device Name: | STOPCOCK 2-WAY, 3-WAY & 4-WAY |
Classification | Stopcock, I.v. Set |
Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-16 |
Decision Date | 1980-09-26 |