FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILMED REPROCESSED COMPRESSION SLEEVES
K Number: K012597
·
Decision Feb 11, 2002
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
64
Review Days
185
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Basic Information
- Device Name
- STERILMED REPROCESSED COMPRESSION SLEEVES
- K Number
- K012597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterilmed, Inc.
- Date Received
- August 10, 2001
- Decision Date
- February 11, 2002
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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