FDA 510(k) Application Details - K241799

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K241799
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch 79853 DE
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Contact Abdulaziz Abdunasimov
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 06/21/2024
Decision Date 03/07/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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 K241799


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