The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Twofer Needle.
Device ID | K832347 |
510k Number | K832347 |
Device Name: | TWOFER NEEDLE |
Classification | Set, I.v. Fluid Transfer |
Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-09-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20085412478429 | K832347 | 000 |
50085412478413 | K832347 | 000 |
50085412478406 | K832347 | 000 |
50085412478390 | K832347 | 000 |
00085412478395 | K832347 | 000 |
00085412478418 | K832347 | 000 |