FDA 510(k) Application Details - K221428

Device Classification Name Oral Wound Dressing

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510(K) Number K221428
Device Name Oral Wound Dressing
Applicant Forward Science LLC
10810 Criaghead Dr
Houston, TX 77025 US
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Contact Brian Pikkula
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Regulation Number 000.0000

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Classification Product Code OLR
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Date Received 05/16/2022
Decision Date 12/22/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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