The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for 10cc Control Syringe.
| Device ID | K873588 |
| 510k Number | K873588 |
| Device Name: | 10CC CONTROL SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MEDI-PLAST INTL., INC. 1050 NORTHFIELD COURT STE.300 Roswell, GA 30076 |
| Contact | Kathleen A Lumberg |
| Correspondent | Kathleen A Lumberg MEDI-PLAST INTL., INC. 1050 NORTHFIELD COURT STE.300 Roswell, GA 30076 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-04 |
| Decision Date | 1987-10-23 |