The following data is part of a premarket notification filed by Henley Intl. with the FDA for Craig Naso-gastric Tube Holder.
Device ID | K862855 |
510k Number | K862855 |
Device Name: | CRAIG NASO-GASTRIC TUBE HOLDER |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
Contact | Ernest J Henley |
Correspondent | Ernest J Henley HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-29 |
Decision Date | 1986-11-04 |