FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUTINOVA FOAM
K Number: K922681
·
Decision Aug 31, 1992
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
221
Applicant Total
15
Review Days
88
Basic Information
- Device Name
- CUTINOVA FOAM
- K Number
- K922681
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JOBST INSTITUTE, INC.
- Date Received
- June 4, 1992
- Decision Date
- August 31, 1992
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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|---|---|---|---|
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| K925154 | JOBST-CUSTOM | Apr 4, 1994 | Substantially Equivalent |
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| K934639 | JOBST ATHROMBIC PUMP - SYSTEM 2500 | Feb 9, 1994 | Substantially Equivalent |
| K921562 | JOBST EXTREMITY PUMP SYSTEM 7500 | Jun 22, 1992 | Substantially Equivalent |
| K920444 | ULTIMATE | Apr 20, 1992 | Substantially Equivalent |
| K912232 | ULCERCARE | Aug 14, 1991 | Substantially Equivalent |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Mar 29, 1991 | Substantially Equivalent |
| K905631 | COMPRINET, COMTESSE AND BELLAVAR STOCKINGS | Mar 7, 1991 | Substantially Equivalent |