FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNTHETIC CAST TAPE
K Number: K883294
·
Decision Aug 30, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
22
Review Days
26
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Basic Information
- Device Name
- SYNTHETIC CAST TAPE
- K Number
- K883294
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Carapace, Inc.
- Date Received
- August 4, 1988
- Decision Date
- August 30, 1988
- Product Code
- LGF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LGF | Component, Cast | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGF), ordered by most recent decision date.
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
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CLINITEX CAST PADDING
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CLINITEX STOCKINETTE
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PROTEC COTTON PADDING BANDAGE
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QUICK-CAST IMMOBILIZER
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FDA Class 1
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CARAPACE STERILE CAST PADDING
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Carapace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Mar 23, 1994 | Unknown |
| K931822 | CARAPACE PELVIC EXAM TRAYS | Mar 7, 1994 | Unknown |
| K931729 | I.V. START KIT | Feb 22, 1994 | Unknown |
| K931820 | CARAPACE STILLWATER BOWL SET | Feb 7, 1994 | Unknown |
| K931669 | CARAPACE DEBRIDEMENT KITS | Feb 7, 1994 | Unknown |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Feb 4, 1994 | Unknown |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Jan 26, 1994 | Unknown |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Jan 26, 1994 | Unknown |
| K931670 | CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS | Jan 25, 1994 | Substantially Equivalent |