The following data is part of a premarket notification filed by Knowltech Ind., Inc. with the FDA for Medicrat, Hypodermic Syringes & Needles.
| Device ID | K875148 |
| 510k Number | K875148 |
| Device Name: | MEDICRAT, HYPODERMIC SYRINGES & NEEDLES |
| Classification | Syringe, Piston |
| Applicant | KNOWLTECH IND., INC. 10275 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Kathleen G Kim |
| Correspondent | Kathleen G Kim KNOWLTECH IND., INC. 10275 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-02-11 |