Device Classification Name |
clip, implantable |
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---|---|---|---|---|
510(k) Number | K080753 | |||
Device Name | AESCULAP ENDOSCOPIC CLIP SYTEM | |||
Applicant |
|
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Applicant Contact | lisa m boyle | |||
Correspondent |
|
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Correspodent Contact | lisa m boyle | |||
Regulation Number | 878.4300 | |||
Classification Product Code |
|
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Subsequent Product Codes |
|
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Date Received | 03/17/2008 | |||
Decision Date | 04/02/2008 | |||
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 | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |