Device Classification Name |
electrosurgical, cutting & coagulation & accessories |
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---|---|---|---|---|
510(k) Number | K111202 | |||
Device Name | SURGICAL TISSUE MANAGEMENT SYSTEM | |||
Applicant |
|
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Applicant Contact | stacy a kluesner, m.s., rac | |||
Correspondent |
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Correspodent Contact | stacy a kluesner, m.s., rac | |||
Regulation Number | 878.4400 | |||
Classification Product Code |
|
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Subsequent Product Codes |
|
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Date Received | 04/29/2011 | |||
Decision Date | 01/20/2012 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
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510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |