The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Pediatric Feeding Tube.
Device ID | K052903 |
510k Number | K052903 |
Device Name: | PEDIATRIC FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul Dryden |
Correspondent | Paul Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-14 |
Decision Date | 2005-11-09 |
Summary: | summary |