FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NORSEN DEBRIDER
K Number: K800647
·
Decision Apr 16, 1980
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
103
Applicant Total
238
Review Days
23
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Basic Information
- Device Name
- NORSEN DEBRIDER
- K Number
- K800647
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medline Industries, Inc.
- Date Received
- March 24, 1980
- Decision Date
- April 16, 1980
- Product Code
- GEN
- 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 |
|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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