FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASONIC TRANSMISSION GEL
K Number: K884503
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
2
Review Days
111
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Basic Information
- Device Name
- ULTRASONIC TRANSMISSION GEL
- K Number
- K884503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Herbert Stanley Co.
- Date Received
- October 25, 1988
- Decision Date
- February 13, 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 Herbert Stanley Co.
| K Number | Device Name | ||
|---|---|---|---|
| K884504 | ELECTRODE GEL | Mar 9, 1989 | Substantially Equivalent |