FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FREEDOM, MODEL 4660
K Number: K001023
·
Decision Sep 22, 2000
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
2
Review Days
176
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Basic Information
- Device Name
- FREEDOM, MODEL 4660
- K Number
- K001023
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson Consumer Companies, Inc.
- Date Received
- March 30, 2000
- Decision Date
- September 22, 2000
- Product Code
- SEJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| SEJ | Wound Dressings Containing Topical Analgesics | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SEJ), ordered by most recent decision date.
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
FDA 510(k)
FDA Unclassified
·Unknown
ALLWOUND
FDA 510(k)
FDA Unclassified
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REGENECARE WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
HEMO-STAT
FDA 510(k)
FDA Unclassified
·Unknown
MICRO-COLL COLLAGEN WOUND SPRAY
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Johnson & Johnson Consumer Companies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062602 | BAND-AID(R) BRAND LIQUID BANDAGE | Dec 11, 2006 | Substantially Equivalent |