FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CURAD COMPRESSION HOSIERY
K Number: K112769
·
Decision Mar 1, 2012
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
238
Review Days
160
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Basic Information
- Device Name
- CURAD COMPRESSION HOSIERY
- K Number
- K112769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medline Industries, Inc.
- Date Received
- September 23, 2011
- Decision Date
- March 1, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWL), ordered by most recent decision date.
MEDLINE ANTI-EMBOLISM STOCKING
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ENCIRCLE COMPRESSION THERAPY STOCKING
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BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
FDA 510(k)
FDA Class 2
·General Hospital
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
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FDA Class 2
·General Hospital
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
FDA 510(k)
FDA Class 2
·General Hospital
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