FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE CAST PADDING
K Number: K801554
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
8
Review Days
27
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Basic Information
- Device Name
- STERILE CAST PADDING
- K Number
- K801554
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1435
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medi-Spec
- Date Received
- July 8, 1980
- Decision Date
- August 4, 1980
- Product Code
- HIX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HIX | Maxwell Spot, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIX), ordered by most recent decision date.
View allOther Clearances by Medi-Spec
| K Number | Device Name | ||
|---|---|---|---|
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Feb 4, 1984 | Substantially Equivalent |
| K812694 | WHISK-R | Oct 26, 1981 | Substantially Equivalent |
| K812426 | UTERINE ASPIRATION CURETTES(RIGID&FLEX) | Oct 8, 1981 | Substantially Equivalent |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Apr 24, 1980 | Substantially Equivalent |
| K800490 | STERILE DRESSING PACK | Mar 12, 1980 | Substantially Equivalent |
| K790952 | CLAMP COVERS | Jun 5, 1979 | Substantially Equivalent |
| K780548 | DISPOSA-LOOPS | Aug 21, 1978 | Substantially Equivalent |