FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALGINATE WOOL FIBER
K Number: K870383
·
Decision Apr 30, 1987
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
9
Applicant Total
6
Review Days
90
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Basic Information
- Device Name
- ALGINATE WOOL FIBER
- K Number
- K870383
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Adri
- Date Received
- January 30, 1987
- Decision Date
- April 30, 1987
- Product Code
- KHR
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KHR | Absorber, Saliva, Paper | FDA class 1 | Dental |
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Other Clearances by Adri
| K Number | Device Name | ||
|---|---|---|---|
| K041268 | SILVERSITE OR CALGITROL | Sep 20, 2004 | Substantially Equivalent |
| K011618 | CALGITROL AG SILVER ALGINATE WOUND DRESSING | Nov 15, 2002 | Substantially Equivalent |
| K000054 | FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN | Mar 13, 2000 | Substantially Equivalent |
| K963656 | FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING | Nov 12, 1996 | Substantially Equivalent |
| K940404 | ALGINATE FIBER TOPICAL WOUND DRESSING | May 4, 1994 | Substantially Equivalent for Some Indications |