The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Kangaroo Entristar Skin-level Gastrostomy Kit.
| Device ID | K954429 |
| 510k Number | K954429 |
| Device Name: | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-22 |
| Decision Date | 1996-03-08 |
| Summary: | summary |