FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTENSION SET, MODELS 1911-512
K Number: K020926
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
14
Review Days
113
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Basic Information
- Device Name
- EXTENSION SET, MODELS 1911-512
- K Number
- K020926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epimed International, Inc.
- Date Received
- March 21, 2002
- Decision Date
- July 12, 2002
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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| K053318 | RX EPIDURAL NEEDLE | Feb 17, 2006 | Substantially Equivalent |
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| K041021 | RF INTRODUCTION CANNULA | Sep 16, 2004 | Substantially Equivalent |
| K041843 | PENCIL POINT NEEDLE | Aug 24, 2004 | Substantially Equivalent |
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | Aug 15, 2003 | Substantially Equivalent |