The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Connecta Plus 1 And Connecta Plus 3 2-way And 3-way Stopcocks.
Device ID | K974083 |
510k Number | K974083 |
Device Name: | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS |
Classification | Stopcock, I.v. Set |
Applicant | OHMEDA MEDICAL 100 MOUNTAIN AVE. Murray Hill, NJ 07974 -2005 |
Contact | Jing Zhang |
Correspondent | Jing Zhang OHMEDA MEDICAL 100 MOUNTAIN AVE. Murray Hill, NJ 07974 -2005 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-29 |
Decision Date | 1998-01-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382903949107 | K974083 | 000 |