FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
K Number: K900664
·
Decision Jul 18, 1990
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
3
Review Days
155
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Basic Information
- Device Name
- DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
- K Number
- K900664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sterimed, Inc.
- Date Received
- February 13, 1990
- Decision Date
- July 18, 1990
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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