FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER/HEMOSTATIC/GERIATRIC
K Number: K780062
·
Decision Feb 14, 1978
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
14
Review Days
33
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Basic Information
- Device Name
- CATHETER/HEMOSTATIC/GERIATRIC
- K Number
- K780062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Kendall Research Center
- Date Received
- January 12, 1978
- Decision Date
- February 14, 1978
- Product Code
- EZL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
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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 |
| K780408 | MICRONET LIGHT DRESSING SPONGE | Mar 22, 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 |