The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Access Systems Needleless Vial Adapter.
| Device ID | K971500 |
| 510k Number | K971500 |
| Device Name: | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-08-18 |
| Summary: | summary |