The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Sherwood Medical Company , Kangaroo, Entristar, Percutaneous Gastrostomy Kit.
| Device ID | K971230 |
| 510k Number | K971230 |
| Device Name: | SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-06-13 |
| Summary: | summary |