The following data is part of a premarket notification filed by Bio-plexus, Inc. with the FDA for Bio-plexus Drop-it Needle Holder.
| Device ID | K963748 |
| 510k Number | K963748 |
| Device Name: | BIO-PLEXUS DROP-IT NEEDLE HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIO-PLEXUS, INC. P.O. BOX 560 Vernon, CT 06066 |
| Contact | Carl R Sahi |
| Correspondent | Carl R Sahi BIO-PLEXUS, INC. P.O. BOX 560 Vernon, CT 06066 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1997-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16641670019230 | K963748 | 000 |