FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE GAUZE PADS 12PLY
K Number: K812711
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
15
Review Days
39
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Basic Information
- Device Name
- STERILE GAUZE PADS 12PLY
- K Number
- K812711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medspec Corp.
- Date Received
- September 24, 1981
- Decision Date
- November 2, 1981
- Product Code
- NAB
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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STERILE GAUZE PADS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| 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 |
| K800278 | MEDSPEC SAFETY PINS | May 2, 1980 | Substantially Equivalent |