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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K240664
Device Name ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
Applicant
SurGenTec, LLC
911 Clint More Rd.
Boca Raton,  FL  33487
Applicant Contact Guilherme Pires
Correspondent
SurGenTec, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
PDQ  
Date Received03/08/2024
Decision Date 08/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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