The following data is part of a premarket notification filed by Codan Medlon, Inc. with the FDA for Codan Medlon Bc110 Vial Adapter Codan Spike.
Device ID | K960921 |
510k Number | K960921 |
Device Name: | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE |
Classification | Set, I.v. Fluid Transfer |
Applicant | CODAN MEDLON, INC. 3325 NORTH GLENOAKS BLVD. Burbank, CA 91504 |
Contact | Thomas J Bouchard |
Correspondent | Thomas J Bouchard CODAN MEDLON, INC. 3325 NORTH GLENOAKS BLVD. Burbank, CA 91504 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-06 |
Decision Date | 1996-04-17 |
Summary: | summary |