The following data is part of a premarket notification filed by Bio-plexus, Inc. with the FDA for Punctur-guard(tm) Blood Collection Needle.
| Device ID | K895024 |
| 510k Number | K895024 |
| Device Name: | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIO-PLEXUS, INC. TWIN PONDS CENTRE (RT. 195) 384Q MERROW ROAD Tolland, CT 06084 |
| Contact | Carl Sahi |
| Correspondent | Carl Sahi BIO-PLEXUS, INC. TWIN PONDS CENTRE (RT. 195) 384Q MERROW ROAD 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 | 1989-08-08 |
| Decision Date | 1990-09-21 |