Device Classification Name |
electrosurgical, cutting & coagulation & accessories |
|||
---|---|---|---|---|
510(k) Number | K081312 | |||
Device Name | ARAGON ONESHOT SYSTEM | |||
Applicant |
|
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Applicant Contact | alan curtis | |||
Correspondent |
|
|||
Correspodent Contact | alan curtis | |||
Regulation Number | 878.4400 | |||
Classification Product Code |
|
|||
Date Received | 05/09/2008 | |||
Decision Date | 10/31/2008 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |