FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HPR EMOLLIENT FOAM
K Number: K113772
·
Decision Feb 9, 2012
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
6
Review Days
49
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Basic Information
- Device Name
- HPR EMOLLIENT FOAM
- K Number
- K113772
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prugen IP Holdings, Inc.
- Date Received
- December 22, 2011
- Decision Date
- February 9, 2012
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Prugen IP Holdings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113774 | HPR PLUS EMOLLIENT FOAM | Feb 9, 2012 | Substantially Equivalent |
| K110732 | EMULSION SB | Jun 3, 2011 | Substantially Equivalent |
| K093159 | PR CREAM | Jun 24, 2010 | Substantially Equivalent |
| K093156 | PRUCLAIR NONSTEROIDAL CREAM | Jun 24, 2010 | Substantially Equivalent |
| K092878 | PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE | Jan 15, 2010 | Substantially Equivalent |