Device Classification Name |
clip, implantable |
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---|---|---|---|---|
510(k) Number | K021407 | |||
Device Name | COALESCENT SURGICAL U-CLIP – OR OTHER TBD AND ACCESSORIES | |||
Original Applicant |
|
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Original Contact | michael a daniel | |||
Regulation Number | 878.4300 | |||
Classification Product Code |
|
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Date Received | 05/03/2002 | |||
Decision Date | 07/03/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |