The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Percutaneous Endoscopic Gastrostomy Kit.
| Device ID | K885220 |
| 510k Number | K885220 |
| Device Name: | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | F Jankowski |
| Correspondent | F Jankowski ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-20 |
| Decision Date | 1989-09-25 |