The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Non-iv Adapter For Infant Ng Tube.
Device ID | K072756 |
510k Number | K072756 |
Device Name: | NON-IV ADAPTER FOR INFANT NG TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | PROMEDIC, INC. 3460 POINTE CREEK CT., #102 Bonita Springs, FL 34134 -2015 |
Contact | Paul Dryden |
Correspondent | Paul Dryden PROMEDIC, INC. 3460 POINTE CREEK CT., #102 Bonita Springs, FL 34134 -2015 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-27 |
Decision Date | 2007-12-19 |
Summary: | summary |