The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Per-q-cath Dressing Change Tray.
| Device ID | K926063 |
| 510k Number | K926063 |
| Device Name: | PER-Q-CATH DRESSING CHANGE TRAY |
| Classification | Wound Dressing Kit |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-06-07 |