The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for Tandem Assembled 3&4 Way Stopcocks.
Device ID | K792124 |
510k Number | K792124 |
Device Name: | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS |
Classification | Stopcock, I.v. Set |
Applicant | TRONOMED, 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 | 1979-10-24 |
Decision Date | 1980-01-16 |