FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSCRUB SURGICAL SCRUB BRUSH
K Number: K870258
·
Decision Feb 24, 1987
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
4
Review Days
32
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Basic Information
- Device Name
- BIOSCRUB SURGICAL SCRUB BRUSH
- K Number
- K870258
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- K. W. Griffen Co.
- Date Received
- January 23, 1987
- Decision Date
- February 24, 1987
- Product Code
- GEC
- 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 |
|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | FDA class 1 | General, Plastic Surgery |
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