FDA Registration
Active
🇺🇸 United States
INSTRUMENT TRAY ECHOPLAN
Reg #: 3011276344
·
FEI: 3011276344
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SWEDEN & MARTINA INC
- Registration Number
- 3011276344
- FEI Number
- 3011276344
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 916 SPINDLETREE AVENUE
- City
- Naperville
- State
- IL
- ZIP
- 60565
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222640
Owner / Operator
- Firm Name
- Sweden & Martina INC
- Operator Number
- 10048147
- Address
- 916 SPINDLETREE AVENUE
- City
- Naperville
- State
- IL
- Postal Code
- 60565
- Country
- US
- Correspondent
- Alessia Pezzato
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-05-29 |
Proprietary Names
INSTRUMENT TRAY ECHOPLAN
OUTLINK2 SUPPLEMENTARY INSTR.
M.I.S.E. EVO KIT
SURGICAL KIT "ONEBOX2"
PREMIUM SUPPLEMENTARY INSTR.
INSTRUMENTS TRAY FOR
PROSTHETIC ACCESSORIES KIT
REMOVAL SCREW KIT
KIT D.B.E. SYSTEM
GLOBAL BONE EXPANDER KIT
SURGICAL KIT ECHOPLAN PRO
SURGICAL KIT ECHOPLAN
SURG. KIT FOR PREMIUM-SHELTA
SURGICAL KIT "ONEBOX"
SURGICAL KIT
Establishment Types
Complaint File Establishment per 21 CFR 820.198