FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HYLATOPIC EMOLLIENT FOAM
K Number: K083024
·
Decision Mar 27, 2009
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
3
Review Days
169
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Basic Information
- Device Name
- HYLATOPIC EMOLLIENT FOAM
- K Number
- K083024
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collegium Pharmaceutical Incorporated
- Date Received
- October 9, 2008
- Decision Date
- March 27, 2009
- 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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