The following data is part of a premarket notification filed by Advanced Clinical Products, Inc. with the FDA for Nephrostomy Drainage Kit (a-150).
| Device ID | K862580 |
| 510k Number | K862580 |
| Device Name: | NEPHROSTOMY DRAINAGE KIT (A-150) |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | ADVANCED CLINICAL PRODUCTS, INC. 10817 TRADE RD. Richmond, VA 23236 |
| Contact | Gene L Mrava |
| Correspondent | Gene L Mrava ADVANCED CLINICAL PRODUCTS, INC. 10817 TRADE RD. Richmond, VA 23236 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-07 |
| Decision Date | 1986-09-23 |