The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Namic Hawkins Universal Drainage Set.
| Device ID | K873954 |
| 510k Number | K873954 |
| Device Name: | NAMIC HAWKINS UNIVERSAL DRAINAGE SET |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | Eamonn P Hobbs |
| Correspondent | Eamonn P Hobbs NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-28 |
| Decision Date | 1988-01-29 |