The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Stopcock 3 Way.
Device ID | K810375 |
510k Number | K810375 |
Device Name: | CENTURION STOPCOCK 3 WAY |
Classification | Stopcock, I.v. Set |
Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 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 | 1981-02-12 |
Decision Date | 1981-02-26 |