FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CURVED FINGER SPLINT
K Number: K820380
·
Decision Mar 1, 1982
Classifications
1
FEI Numbers
416
Registration Numbers
416
Same Product Code
35
Applicant Total
12
Review Days
20
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Basic Information
- Device Name
- CURVED FINGER SPLINT
- K Number
- K820380
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Conco Medical Co.
- Date Received
- February 9, 1982
- Decision Date
- March 1, 1982
- Product Code
- ILH
- 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 |
|---|---|---|---|
| ILH | Splint, Hand, And Components | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILH), ordered by most recent decision date.
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FINGER FLEXION SPLINT
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UNIVERSAL WRIST SPLINT & FOREARM SPLINT
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WRIST SUPPORT
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Other Clearances by Conco Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K904819 | SHUR-LOCK ICE WRAP SYSTEM | Dec 6, 1990 | Substantially Equivalent |
| K821701 | RAPIDO-LASTIC IN STERILE FORM | Jul 22, 1982 | Substantially Equivalent |
| K820826 | STAX FINGER SPLINT | Apr 8, 1982 | Substantially Equivalent |
| K820381 | FINGER PROTECTOR | Mar 1, 1982 | Substantially Equivalent |
| K820382 | FROG SPLINT | Mar 1, 1982 | Substantially Equivalent |
| K820383 | FINGER COT | Feb 24, 1982 | Substantially Equivalent |
| K760139 | BANDAGE, E-COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent |
| K760138 | BANDAGE, CEB COTTON ELASTIC | Jul 19, 1976 | Substantially Equivalent |
| K760140 | BANDAGE, WRINKY-LASTIC ELASTIC GAUZE | Jul 19, 1976 | Substantially Equivalent |
| K760142 | BANDAGE, RAPIDO-LASTIC COTTON/NYLON | Jul 19, 1976 | Substantially Equivalent |