The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Syringe Additive Iv Admin. Sets.
| Device ID | K841361 |
| 510k Number | K841361 |
| Device Name: | SYRINGE ADDITIVE IV ADMIN. SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-05-21 |