The following data is part of a premarket notification filed by Bioject Medical Technologies Inc. with the FDA for Q-cap Needle-free Reconstitution 13mm Vial Adapter, Model 6100-01.
| Device ID | K041564 |
| 510k Number | K041564 |
| Device Name: | Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BIOJECT MEDICAL TECHNOLOGIES INC. 211 SOMERVILLE ROAD Bedminster, NJ 07921 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter BIOJECT MEDICAL TECHNOLOGIES INC. 211 SOMERVILLE ROAD Bedminster, NJ 07921 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-10 |
| Decision Date | 2004-07-16 |
| Summary: | summary |