The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Babistick.
| Device ID | K933365 |
| 510k Number | K933365 |
| Device Name: | BABISTICK |
| Classification | Lancet, Blood |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Contact | John H Barrett |
| Correspondent | John H Barrett GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. Buffalo, NY 14240 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1993-10-19 |