FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TENDER-SORB DRAIN SPONGES
K Number: K802225
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
14
Review Days
14
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Basic Information
- Device Name
- TENDER-SORB DRAIN SPONGES
- K Number
- K802225
- 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
- September 12, 1980
- Decision Date
- September 26, 1980
- 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 |
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Other Clearances by Kendall Research Center
| K Number | Device Name | ||
|---|---|---|---|
| K781357 | T.E.D. SEQUENTIAL COMPRESSION SLEEVES | Sep 20, 1978 | Substantially Equivalent |
| K780408 | MICRONET LIGHT DRESSING SPONGE | Mar 22, 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 |
| K771452 | CONFORM STRETCH BANDAGE (5SIZES) | Sep 12, 1977 | Substantially Equivalent |
| K771563 | CONFORM ELASTIC NETTING | Sep 12, 1977 | Substantially Equivalent |