The following data is part of a premarket notification filed by Bio-plexus, Inc. with the FDA for Punctur-guard Winged Set.
| Device ID | K961251 |
| 510k Number | K961251 |
| Device Name: | PUNCTUR-GUARD WINGED SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIO-PLEXUS, INC. 384 MERROW RD. Tolland, CT 06084 |
| Contact | Carl Sahi |
| Correspondent | Carl Sahi BIO-PLEXUS, INC. 384 MERROW RD. Tolland, CT 06084 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-06-27 |
| Summary: | summary |