FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
K Number: K831226
·
Decision May 16, 1983
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
26
Review Days
31
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Basic Information
- Device Name
- MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450
- K Number
- K831226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ballard Medical Products
- Date Received
- April 15, 1983
- Decision Date
- May 16, 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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| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | Sep 11, 1998 | Substantially Equivalent |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |