The following data is part of a premarket notification filed by Winfield Industries with the FDA for Venipuncture Kit.
| Device ID | K954823 |
| 510k Number | K954823 |
| Device Name: | VENIPUNCTURE KIT |
| Classification | Set, Administration, Intravascular |
| Applicant | WINFIELD INDUSTRIES 9750 DISTRIBUTION AVE. San Diego, CA 92121 |
| Contact | David Olmstead |
| Correspondent | David Olmstead WINFIELD INDUSTRIES 9750 DISTRIBUTION AVE. San Diego, CA 92121 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-20 |
| Decision Date | 1996-01-30 |