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 |