FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE HEMOSTATS
K Number: K920298
·
Decision Aug 11, 1992
Classifications
1
FEI Numbers
182
Registration Numbers
182
Same Product Code
14
Applicant Total
4
Review Days
202
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Basic Information
- Device Name
- DISPOSABLE HEMOSTATS
- K Number
- K920298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Falcon Instruments, Inc.
- Date Received
- January 22, 1992
- Decision Date
- August 11, 1992
- Product Code
- HRQ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HRQ | Hemostat | FDA class 1 | General, Plastic Surgery |
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