FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-EM/GP STOCKINGS
K Number: K955138
·
Decision Dec 13, 1995
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
15
Review Days
30
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Basic Information
- Device Name
- ANTI-EM/GP STOCKINGS
- K Number
- K955138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jobst Institute, Inc.
- Date Received
- November 13, 1995
- Decision Date
- December 13, 1995
- Product Code
- DWL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | FDA class 2 | General Hospital |
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Other Clearances by Jobst Institute, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |