The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Bec Needleless Injection Site.
| Device ID | K961327 |
| 510k Number | K961327 |
| Device Name: | BEC NEEDLELESS INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 705 FRONT ST. Toledo, OH 43605 |
| Contact | James R Kulla |
| Correspondent | James R Kulla BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 705 FRONT ST. Toledo, OH 43605 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-05-15 |
| Summary: | summary |