The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Safe Mate I.v. Extension Sets.
| Device ID | K962801 |
| 510k Number | K962801 |
| Device Name: | SAFE MATE I.V. EXTENSION SETS |
| 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 | 1996-07-18 |
| Decision Date | 1996-08-28 |
| Summary: | summary |