FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-RAY DETECTABLE BAND
K Number: K812017
·
Decision Nov 20, 1981
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
3
Review Days
126
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Basic Information
- Device Name
- X-RAY DETECTABLE BAND
- K Number
- K812017
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Isramed, Inc.
- Date Received
- July 17, 1981
- Decision Date
- November 20, 1981
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
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