The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Hand Controlled Syringe.
| Device ID | K942329 |
| 510k Number | K942329 |
| Device Name: | HAND CONTROLLED SYRINGE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Contact | Frederick A Gustafson |
| Correspondent | Frederick A Gustafson ABBOTT LABORATORIES D-389, AP-30 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -3537 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-16 |
| Decision Date | 1994-06-20 |