The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Flexible Stainless Steel Stylet For Enternal Feedi.
Device ID | K844174 |
510k Number | K844174 |
Device Name: | FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | EXCO, INC. P.O. BOX 1348 Wall, NJ 07719 |
Contact | John Y Chalakani |
Correspondent | John Y Chalakani EXCO, INC. P.O. BOX 1348 Wall, NJ 07719 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-25 |
Decision Date | 1984-12-07 |