FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FOAM CARE ONE STEP PREP
K Number: K843636
·
Decision Nov 16, 1984
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
26
Review Days
60
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Basic Information
- Device Name
- FOAM CARE ONE STEP PREP
- K Number
- K843636
- 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
- September 17, 1984
- Decision Date
- November 16, 1984
- 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 |
Similar 510(k) Clearances
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STERILE SCRUBBY SCRUB BRUSH
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STERI-CLENS
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Other Clearances by Ballard Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K030721 | QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE | Mar 31, 2003 | Substantially Equivalent |
| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Oct 11, 2002 | Substantially Equivalent |
| K013892 | LUTZ NEEDLE | Jul 11, 2002 | Substantially Equivalent |
| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | Mar 28, 2000 | Substantially Equivalent |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | Oct 20, 1999 | Substantially Equivalent |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | May 3, 1999 | Substantially Equivalent |
| 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 |