FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZON SURGICAL LIGATING AND MARKING CLIP
K Number: K901303
·
Decision Jun 5, 1990
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- HORIZON SURGICAL LIGATING AND MARKING CLIP
- K Number
- K901303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Horizon Surgical, Inc.
- Date Received
- March 20, 1990
- Decision Date
- June 5, 1990
- Product Code
- DSS
- 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 |
|---|---|---|---|
| DSS | Clip, Vascular | FDA class 2 | Cardiovascular |
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