FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULCERCARE
K Number: K912232
·
Decision Aug 14, 1991
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
15
Review Days
86
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Basic Information
- Device Name
- ULCERCARE
- K Number
- K912232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jobst Institute, Inc.
- Date Received
- May 20, 1991
- Decision Date
- August 14, 1991
- Product Code
- MCY
- 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 |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCY), ordered by most recent decision date.
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
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FDA Class 2
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CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
WOUND CARE COMPRESSION SYSTEM (WCCS)
FDA 510(k)
FDA Class 2
·General Hospital
DRESSING CHANGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 1
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 2
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Jobst Institute, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955138 | ANTI-EM/GP STOCKINGS | Dec 13, 1995 | Substantially Equivalent |
| K953763 | GLADIATOR ANTISHOCK PANTS | Nov 28, 1995 | Substantially Equivalent |
| K925583 | JOBSKIN CONTINUING CARE | Apr 4, 1994 | Substantially Equivalent |
| K925154 | JOBST-CUSTOM | Apr 4, 1994 | Substantially Equivalent |
| K934639 | JOBST ATHROMBIC PUMP - SYSTEM 2500 | Feb 9, 1994 | Substantially Equivalent |
| K922681 | CUTINOVA FOAM | Aug 31, 1992 | Substantially Equivalent |
| K921562 | JOBST EXTREMITY PUMP SYSTEM 7500 | Jun 22, 1992 | Substantially Equivalent |
| K920444 | ULTIMATE | Apr 20, 1992 | Substantially Equivalent |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Mar 29, 1991 | Substantially Equivalent |
| K905631 | COMPRINET, COMTESSE AND BELLAVAR STOCKINGS | Mar 7, 1991 | Substantially Equivalent |