The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Pharmacy Additive Syringe Set.
| Device ID | K800213 |
| 510k Number | K800213 |
| Device Name: | PHARMACY ADDITIVE SYRINGE SET |
| Classification | Container, Liquid Medication, Graduated |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYW |
| CFR Regulation Number | 880.6430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-01 |
| Decision Date | 1980-02-26 |