The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Kim Naso-intestinal Tube.
Device ID | K882918 |
510k Number | K882918 |
Device Name: | KIM NASO-INTESTINAL TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | Steen, Phd |
Correspondent | Steen, Phd SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-12 |
Decision Date | 1988-12-05 |