FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
ALGOPLAQUE HYDROCOLLOID DRESSING
K Number: K970518
·
Decision Mar 21, 1997
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
2
Review Days
38
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Basic Information
- Device Name
- ALGOPLAQUE HYDROCOLLOID DRESSING
- K Number
- K970518
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Laboratoires Urgo S.A.
- Date Received
- February 11, 1997
- Decision Date
- March 21, 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 Laboratoires Urgo S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K974348 | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING | Feb 13, 1998 | Substantially Equivalent |