The following data is part of a premarket notification filed by Intl. Hospital Products, Inc. with the FDA for Baker Intestinal Tube, Twin Cuff.
Device ID | K792333 |
510k Number | K792333 |
Device Name: | BAKER INTESTINAL TUBE, TWIN CUFF |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | INTL. HOSPITAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-19 |
Decision Date | 1980-01-16 |