FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAUZE SPONGE
K Number: K953812
·
Decision Oct 2, 1995
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
9
Applicant Total
19
Review Days
61
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Basic Information
- Device Name
- GAUZE SPONGE
- K Number
- K953812
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remington Medical, Inc.
- Date Received
- August 2, 1995
- Decision Date
- October 2, 1995
- 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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