FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DAVRON PROF. SCRUB BRUSH-DRY/STERILE
K Number: K831488
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
4
Review Days
29
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Basic Information
- Device Name
- DAVRON PROF. SCRUB BRUSH-DRY/STERILE
- K Number
- K831488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Minnetonka, Inc.
- Date Received
- May 10, 1983
- Decision Date
- June 8, 1983
- 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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Other Clearances by Minnetonka, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883619 | MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K883566 | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | Sep 1, 1989 | Substantially Equivalent for Some Indications |
| K860843 | CHECK-UP PLAQUE FIGHTING GUM | May 21, 1986 | Substantially Equivalent |