FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
K Number: K842483
·
Decision Aug 31, 1984
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
8
Review Days
67
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Basic Information
- Device Name
- SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
- K Number
- K842483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Santa Barbara Medco, Inc.
- Date Received
- June 25, 1984
- Decision Date
- August 31, 1984
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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Other Clearances by Santa Barbara Medco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850492 | NASAL SEPTAL BUTTON | Mar 7, 1985 | Substantially Equivalent |
| K823921 | PHYSICIANS CHOICE SILICONE EAR PUTTY | Mar 28, 1983 | Substantially Equivalent |
| K821187 | MEDCO CUSTOM EAR PROTECTOR MOLD KIT | May 27, 1982 | Substantially Equivalent |
| K812069 | BORES* DEPTH GAUGE | Aug 31, 1981 | Substantially Equivalent |
| K812071 | RK IV SURGICAL BLADES | Aug 31, 1981 | Substantially Equivalent |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Aug 18, 1981 | Substantially Equivalent |
| K802638 | OTOLOGICAL VENTILATION TUBES | Nov 12, 1980 | Substantially Equivalent |