FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDSPEC PACKING GAUZE
K Number: K800281
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
111
Applicant Total
15
Review Days
36
Basic Information
- Device Name
- MEDSPEC PACKING GAUZE
- K Number
- K800281
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- MEDSPEC CORP.
- Date Received
- February 5, 1980
- Decision Date
- March 12, 1980
- 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 |
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KENSORB
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Other Clearances by MEDSPEC CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K813012 | STERILE BASIN SETS | Nov 6, 1981 | Substantially Equivalent |
| K812707 | STERILE DISSECTOR SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812711 | STERILE GAUZE PADS 12PLY | Nov 2, 1981 | Substantially Equivalent |
| K812710 | STERILE LAPAROTOMY SPONGES-X-RAY DETECT | Nov 2, 1981 | Substantially Equivalent |
| K812709 | STERILE DENTAL ROLL | Oct 23, 1981 | Substantially Equivalent |
| K810071 | STERILE SILICONE TUBING | Feb 12, 1981 | Substantially Equivalent |
| K810069 | STERILE AIRWAY | Feb 2, 1981 | Substantially Equivalent |
| K802060 | STERILE TONSIL SPONGES | Oct 10, 1980 | Substantially Equivalent |
| K801069 | STERILE ISOLATION GOWN | May 20, 1980 | Substantially Equivalent |
| K801068 | STERILE ABDOMINAL PAD | May 20, 1980 | Substantially Equivalent |