FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
K Number: K924958
·
Decision Jun 7, 1993
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
4
Review Days
250
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Basic Information
- Device Name
- BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
- K Number
- K924958
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medical Insights, Inc.
- Date Received
- September 30, 1992
- Decision Date
- June 7, 1993
- Product Code
- KDD
- 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 |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | FDA class 1 | General, Plastic Surgery |
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