FDA 510(k) Application Details - K231325

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K231325
Device Name Dressing, Wound, Collagen
Applicant StimLabs, LLC
1225 Northmeadow Parkway, Suite 104
Roswell, GA 30076 US
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Contact Melissa O'Connor
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 05/08/2023
Decision Date 02/02/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K231325


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