The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Lifeshield Blunt Cannula.
| Device ID | K963351 |
| 510k Number | K963351 |
| Device Name: | LIFESHIELD BLUNT CANNULA |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Contact | Jill N Sackett |
| Correspondent | Jill N Sackett ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1997-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521082905 | K963351 | 000 |
| 20884521082899 | K963351 | 000 |