The following data is part of a premarket notification filed by Macbrud Corp. Medical Div. with the FDA for Needle-shield.
| Device ID | K900282 |
| 510k Number | K900282 |
| Device Name: | NEEDLE-SHIELD |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
| Contact | Gray Lary |
| Correspondent | Gray Lary MACBRUD CORP. MEDICAL DIV. 6280 SUNSET DRIVE #411 Miami, FL 33143 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-21 |
| Decision Date | 1990-02-28 |