FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMOSTAT, SURGICAL (VARIOUS TYPES)
K Number: K920883
·
Decision Mar 13, 1992
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
1
Applicant Total
1
Review Days
16
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Basic Information
- Device Name
- HEMOSTAT, SURGICAL (VARIOUS TYPES)
- K Number
- K920883
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S.T.S Instruments
- Date Received
- February 26, 1992
- Decision Date
- March 13, 1992
- Product Code
- EMD
- 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 |
|---|---|---|---|
| EMD | Hemostat, Surgical | FDA class 1 | Dental |
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