The following data is part of a premarket notification filed by Knight Medical, Inc. with the FDA for Tube Gastrostomy.
| Device ID | K903086 |
| 510k Number | K903086 |
| Device Name: | TUBE GASTROSTOMY |
| Classification | Tube, Gastro-enterostomy |
| Applicant | KNIGHT MEDICAL, INC. 320 CHARLES ST. Cambridge, MA 02141 |
| Contact | Len Cooke |
| Correspondent | Len Cooke KNIGHT MEDICAL, INC. 320 CHARLES ST. Cambridge, MA 02141 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-12 |
| Decision Date | 1990-11-20 |