The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Pediatric And Infant Cath Kits.
| Device ID | K905016 |
| 510k Number | K905016 |
| Device Name: | PEDIATRIC AND INFANT CATH KITS |
| Classification | Collector, Urine, Pediatric, For Indwelling Catheter |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Leo Basta |
| Correspondent | Leo Basta DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | FFH |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1990-12-20 |