The following data is part of a premarket notification filed by Beech Medical, Inc. with the FDA for Benzing Retrograde Admin. Set.
Device ID | K823373 |
510k Number | K823373 |
Device Name: | BENZING RETROGRADE ADMIN. SET |
Classification | Stopcock, I.v. Set |
Applicant | BEECH MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-12 |
Decision Date | 1982-12-30 |