FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRONET LIGHT DRESSING SPONGE
K Number: K780408
·
Decision Mar 22, 1978
Classifications
1
FEI Numbers
585
Registration Numbers
585
Same Product Code
67
Applicant Total
14
Review Days
9
Basic Information
- Device Name
- MICRONET LIGHT DRESSING SPONGE
- K Number
- K780408
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- KENDALL RESEARCH CENTER
- Date Received
- March 13, 1978
- Decision Date
- March 22, 1978
- 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
Other 510(k) clearances with the same product code (NAB), ordered by most recent decision date.
IVALON EXTERNAL SPONGE
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ISOLYER (4X4, 8PLY)
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OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
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MULTI-TRAUMA DRESSING
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K-BAND AND K-CREPE
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STERILE GAUZE PADS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by KENDALL RESEARCH CENTER
| K Number | Device Name | ||
|---|---|---|---|
| K802225 | TENDER-SORB DRAIN SPONGES | Sep 26, 1980 | Substantially Equivalent |
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | Sep 20, 1978 | Substantially Equivalent |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC | Feb 14, 1978 | Substantially Equivalent |
| K780120 | ANESTHESIA TRAY, CAUDAL | Feb 6, 1978 | Substantially Equivalent |
| K772134 | SYRINGE, IRRIGATION, PRE-FILLED | Nov 28, 1977 | Substantially Equivalent |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Nov 28, 1977 | Substantially Equivalent |
| K771655 | CURITY PEAKOMETER | Oct 14, 1977 | Substantially Equivalent |
| K771079 | CURITY IRRIGATION TRAY | Sep 15, 1977 | Substantially Equivalent |
| K771563 | CONFORM ELASTIC NETTING | Sep 12, 1977 | Substantially Equivalent |
| K771452 | CONFORM STRETCH BANDAGE (5SIZES) | Sep 12, 1977 | Substantially Equivalent |