FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
K Number: K973657
·
Decision Dec 1, 1997
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
4
Review Days
67
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Basic Information
- Device Name
- ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
- K Number
- K973657
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Maersk Medical, Ltd.
- Date Received
- September 25, 1997
- Decision Date
- December 1, 1997
- Product Code
- MGP
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
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Other Clearances by Maersk Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K004028 | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING | Mar 27, 2001 | Substantially Equivalent |
| K990810 | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING | Sep 17, 1999 | Substantially Equivalent |
| K970566 | ARGLAES FILM DRESSING | Jul 29, 1997 | Substantially Equivalent for Some Indications |