FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
INERPAN(TM) TEMPORARY WOUND DRESSING
K Number: K911161
·
Decision Jun 27, 1991
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
80
Applicant Total
1
Review Days
104
Basic Information
- Device Name
- INERPAN(TM) TEMPORARY WOUND DRESSING
- K Number
- K911161
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- LABORATORIES DELALANDE
- Date Received
- March 15, 1991
- Decision Date
- June 27, 1991
- 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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