The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Hypoint Needle.
Device ID | K070440 |
510k Number | K070440 |
Device Name: | BD HYPOINT NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Aileen C Gilbert |
Correspondent | Aileen C Gilbert BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-15 |
Decision Date | 2007-03-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903013901 | K070440 | 000 |
50382903002646 | K070440 | 000 |
50382903002639 | K070440 | 000 |
50382903002554 | K070440 | 000 |
50382903002493 | K070440 | 000 |
50382903002080 | K070440 | 000 |
50382903002530 | K070440 | 000 |