Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid |
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---|---|---|---|---|
510(k) Number | K050611 | |||
Device Name | ENDOTINE RIBBON | |||
Applicant |
|
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Applicant Contact | linda ruedy | |||
Correspondent |
|
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Correspodent Contact | linda ruedy | |||
Regulation Number | 878.4493 | |||
Classification Product Code |
|
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Date Received | 03/09/2005 | |||
Decision Date | 04/06/2005 | |||
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 |