The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Infant Feeding Tube.
Device ID | K872097 |
510k Number | K872097 |
Device Name: | INFANT FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
Contact | George J Pluta |
Correspondent | George J Pluta TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-08-25 |