FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE ULTRASOUND TRANSMISSION GEL
K Number: K894490
·
Decision Oct 5, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- STERILE ULTRASOUND TRANSMISSION GEL
- K Number
- K894490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Swedish Trade Council USA
- Date Received
- July 18, 1989
- Decision Date
- October 5, 1989
- Product Code
- JOT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOT | Electrode, Gel, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Swedish Trade Council USA
| K Number | Device Name | ||
|---|---|---|---|
| K903034 | RENALYZER PRX 90 | Mar 13, 1991 | Substantially Equivalent |