The following data is part of a premarket notification filed by Bio-plexus, Inc. with the FDA for Punctur-guard Winged Set For Blood Collection.
| Device ID | K003827 |
| 510k Number | K003827 |
| Device Name: | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIO-PLEXUS, INC. 129 RESERVOIR RD. Vernon, CT 06066 -5705 |
| Contact | Paul A Tenthorey |
| Correspondent | Paul A Tenthorey BIO-PLEXUS, INC. 129 RESERVOIR RD. Vernon, CT 06066 -5705 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-01-08 |