The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Peg Guidewire System Gastrostomy Tube Kit.
Device ID | K923983 |
510k Number | K923983 |
Device Name: | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Contact | Robert J Lang |
Correspondent | Robert J Lang SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis, MN 55440 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-07 |
Decision Date | 1993-04-06 |