The following data is part of a premarket notification filed by Becton Dickinson Consumer Products with the FDA for B-d Safe-clip.
Device ID | K943683 |
510k Number | K943683 |
Device Name: | B-D SAFE-CLIP |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
Contact | Peter Zurlo |
Correspondent | Peter Zurlo BECTON DICKINSON CONSUMER PRODUCTS ONE BECTON DR. Franklin Lake, NJ 07417 -1883 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-29 |
Decision Date | 1994-10-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903283359 | K943683 | 000 |
50382903282352 | K943683 | 000 |