FDA Registration
Active
🇺🇸 United States
HK Klein TDD Pump
Reg #: 2027804
·
FEI: 1000125732
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HK SURGICAL, INC.
- Registration Number
- 2027804
- FEI Number
- 1000125732
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1271 PUERTA DEL SOL
- City
- SAN CLEMENTE
- State
- CA
- ZIP
- 92673
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123822
Owner / Operator
- Firm Name
- HK SURGICAL, INC.
- Operator Number
- 9000274
- Address
- 1271 PUERTA DEL SOL, --
- City
- San Clemente
- State
- CA
- Postal Code
- 92673
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2014-02-04 |
Proprietary Names
HK Klein TDD Pump
Klein Touch Pump
HK CV Single Spike Infiltration Tubing
Double Spike Infiltration Tubing
Single Spike Infiltration Tubing
HK 2X Infiltration Tubing
Klein Tumescent Infiltration Pump KTIP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility