Device Classification Name |
suture, surgical, absorbable, polydioxanone |
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---|---|---|---|---|---|
510(k) Number | K080680 | ||||
Device Name | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE | ||||
Applicant |
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Applicant Contact | trudy d estridge | ||||
Correspondent |
|
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Correspodent Contact | trudy d estridge | ||||
Regulation Number | 878.4840 | ||||
Classification Product Code |
|
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Date Received | 03/10/2008 | ||||
Decision Date | 03/21/2008 | ||||
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 |