FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE
K Number: K922874
·
Decision Sep 11, 1992
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE
- K Number
- K922874
- 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
- Supra Instruments, Inc.
- Date Received
- June 15, 1992
- Decision Date
- September 11, 1992
- Product Code
- MDM
- 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 |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
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