FDA Registration
Active
🇺🇸 United States
Kit, IRK, Endowrist Instruments, IS1200/2000/3000
Reg #: 3014309390
·
FEI: 3014309390
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Mass Precision, Inc.
- Registration Number
- 3014309390
- FEI Number
- 3014309390
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 46555 Landing Parkway
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131861
Owner / Operator
- Firm Name
- Mass Precision, Inc.
- Operator Number
- 10081926
- Address
- 2110 Oakland Road
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Matthew Stucky
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-05-26 |
Proprietary Names
Kit, IRK, Endowrist Instruments, IS1200/2000/3000
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)