The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Needle Container.
| Device ID | K874430 |
| 510k Number | K874430 |
| Device Name: | NEEDLE CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234 |
| Contact | Gene Zamba |
| Correspondent | Gene Zamba AMERICAN MEDICAL TECHNOLOGY, INC. C/O VENTURE MGMT CONSULTING BOX 160 GRAND VIEW TERRACE EXT Brooklyn, CT 06234 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-01-04 |