FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO WOUN'DRES
K Number: K991202
·
Decision Jun 4, 1999
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
54
Review Days
74
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Basic Information
- Device Name
- MODIFICATION TO WOUN'DRES
- K Number
- K991202
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- March 22, 1999
- Decision Date
- June 4, 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 |
Similar 510(k) Clearances
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FDA Unclassified
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SILVERSEAL
FDA 510(k)
FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
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