Device Classification Name |
elastomer, silicone, for scar management |
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---|---|---|---|---|
510(k) Number | K991970 | |||
Device Name | SCAREASE SHEETS & SCAREASE GEL | |||
Applicant |
|
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Applicant Contact | rob fritzenkotter | |||
Correspondent |
|
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Correspodent Contact | rob fritzenkotter | |||
Regulation Number | 878.4025 | |||
Classification Product Code |
|
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Date Received | 06/11/1999 | |||
Decision Date | 10/25/1999 | |||
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 |