FDA 510(k)
FDA unclassified
Substantially Equivalent
🇿🇦 South Africa
BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
K Number: K984082
·
Decision Jan 28, 1999
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
2
Review Days
73
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Basic Information
- Device Name
- BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
- K Number
- K984082
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Emox 911 CC
- Date Received
- November 16, 1998
- Decision Date
- January 28, 1999
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
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Other Clearances by Emox 911 CC
| K Number | Device Name | ||
|---|---|---|---|
| K984081 | EMOX | Mar 17, 1999 | Substantially Equivalent |