The following data is part of a premarket notification filed by Moss Medical Products with the FDA for Y2k2 Enternal Tube Fluid Filter.
| Device ID | K051206 |
| 510k Number | K051206 |
| Device Name: | Y2K2 ENTERNAL TUBE FLUID FILTER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MOSS MEDICAL PRODUCTS 4049 NY 150 West Sand Lake, NY 12196 |
| Contact | Gerald Moss |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-05-11 |
| Decision Date | 2005-11-02 |
| Summary: | summary |