FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
KIT, SURGICAL INSTRUMENT, DISPOSABLE
K Number: K925905
·
Decision Jun 16, 1993
Classifications
1
FEI Numbers
329
Registration Numbers
330
Same Product Code
61
Applicant Total
1
Review Days
210
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Basic Information
- Device Name
- KIT, SURGICAL INSTRUMENT, DISPOSABLE
- K Number
- K925905
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Kay Medical Concepts
- Date Received
- November 18, 1992
- Decision Date
- June 16, 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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