FDA 510(k) Application Details - K240753

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K240753
Device Name Dressing, Wound, Collagen
Applicant Reprise Biomedical, Inc.
17400 Medina Road
Suite 100
Plymouth, MN 55447 US
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Contact Erin Badali
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 03/20/2024
Decision Date 04/19/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240753


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