FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHYSICIANS CHOICE SILICONE EAR PUTTY
K Number: K823921
·
Decision Mar 28, 1983
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
1
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- PHYSICIANS CHOICE SILICONE EAR PUTTY
- K Number
- K823921
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Santa Barbara Medco, Inc.
- Date Received
- December 28, 1982
- Decision Date
- March 28, 1983
- Product Code
- LDG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| LDG | Kit, Earmold, Impression | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LDG), ordered by most recent decision date.
View allOther Clearances by Santa Barbara Medco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850492 | NASAL SEPTAL BUTTON | Mar 7, 1985 | Substantially Equivalent |
| K842483 | SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC | Aug 31, 1984 | 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 |