The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Lock-sure Single Pass Drainage Catheter, Z10005/7/9.
| Device ID | K990689 |
| 510k Number | K990689 |
| Device Name: | ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 |
| Classification | Catheter, Nephrostomy |
| Applicant | ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Contact | Priscilla Whitehead Cox |
| Correspondent | Priscilla Whitehead Cox ZCV ,INC. 298 FERNWOOD AVE. Edison, NJ 08837 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-03 |
| Decision Date | 1999-09-03 |
| Summary: | summary |