The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Bec Shrouded Plastic Cannula.
| Device ID | K961328 |
| 510k Number | K961328 |
| Device Name: | BEC SHROUDED PLASTIC CANNULA |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 705 FRONT ST. Toledo, OH 43605 |
| Contact | James P Kulla |
| Correspondent | James P Kulla BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 705 FRONT ST. Toledo, OH 43605 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-05-30 |
| Summary: | summary |