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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K232646
Device Name Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
Applicant
Cook Biotech Incorporated
1425 Innovation Place
West Lafayetta,  IN  47906
Applicant Contact Christopher Lotzow
Correspondent
Cook Biotech Incorporated
1425 Innovation Place
West Lafayetta,  IN  47906
Correspondent Contact Christopher Lotzow
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received08/30/2023
Decision Date 05/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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