The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Maclee/boin Medica Sterile Needle & Syringe 1ml/cc.
| Device ID | K864780 |
| 510k Number | K864780 |
| Device Name: | MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC |
| Classification | Syringe, Piston |
| Applicant | MAC LEE MEDICAL PRODUCTS 2900 S.W. ATWOOD Topeka, KS 66614 |
| Contact | George E Liesmann |
| Correspondent | George E Liesmann MAC LEE MEDICAL PRODUCTS 2900 S.W. ATWOOD Topeka, KS 66614 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-08 |
| Decision Date | 1986-12-23 |