The following data is part of a premarket notification filed by American Medical Technology, Inc. with the FDA for Plastic Tubing Connector.
| Device ID | K874360 |
| 510k Number | K874360 |
| Device Name: | PLASTIC TUBING CONNECTOR |
| Classification | Tubing, Fluid Delivery |
| 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 | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-23 |
| Decision Date | 1987-11-17 |