The following data is part of a premarket notification filed by Falcon Medical Industries, Inc. with the FDA for Blood Lancet.
| Device ID | K865016 |
| 510k Number | K865016 |
| Device Name: | BLOOD LANCET |
| Classification | Lancet, Blood |
| Applicant | FALCON MEDICAL INDUSTRIES, INC. 1640 NORTH NEWPORT AVE. Delano, FL 32724 |
| Contact | Steve Trapper |
| Correspondent | Steve Trapper FALCON MEDICAL INDUSTRIES, INC. 1640 NORTH NEWPORT AVE. Delano, FL 32724 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-01-12 |