Device Classification Name |
wound dressing with animal-derived material(s)
|
510(k) Number |
K061494 |
Device Name |
DERMADAPT WOUND DRESSING |
Applicant |
PEGASUS BIOLOGICS, INC. |
6 JENNER |
SUITE 150 |
IRVINE,
CA
92618
|
|
Applicant Contact |
PAMELA MISAJON |
Correspondent |
PEGASUS BIOLOGICS, INC. |
6 JENNER |
SUITE 150 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
PAMELA MISAJON |
Classification Product Code |
|
Date Received | 05/31/2006 |
Decision Date | 09/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|