ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
FDA 510(k) clearance K990689 · decided 1999-09-03
Clearance details
- K-number
- K990689
- Device name
- ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
- Applicant
- Zcv ,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-03
- Decision date
- 1999-09-03
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- LJE
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Edison, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.