FDA 510(k)
FDA unclassified
Substantially Equivalent
🇮🇪 Ireland
COLLAGEN SPONGE
K Number: K092805
·
Decision Feb 16, 2010
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
6
Review Days
158
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Basic Information
- Device Name
- COLLAGEN SPONGE
- K Number
- K092805
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innocoll Pharmaceuticals
- Date Received
- September 11, 2009
- Decision Date
- February 16, 2010
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Innocoll Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K133290 | COLLACARE DENTAL | May 1, 2014 | Substantially Equivalent |
| K120339 | PROCOLL | Jun 21, 2012 | Substantially Equivalent |
| K100574 | COLLEXA | Oct 28, 2010 | Substantially Equivalent |
| K081782 | COLLIEVA | Sep 30, 2008 | Substantially Equivalent |
| K061746 | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID | Oct 2, 2006 | Substantially Equivalent |