FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
K Number: K864529
·
Decision Dec 16, 1986
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36
- K Number
- K864529
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Elof Hansson, Inc.
- Date Received
- November 17, 1986
- Decision Date
- December 16, 1986
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
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Other Clearances by Elof Hansson, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864528 | TOWELS | Dec 18, 1986 | Substantially Equivalent |