FDA 510(k) Application Details - K240506

Device Classification Name Endoscope Holder

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510(K) Number K240506
Device Name Endoscope Holder
Applicant KARL STORZ Endoscopy America, Inc
2151 E. Grand Avenue
El Segundo, CA 90245 US
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Contact Mario Trujillo
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Regulation Number 876.1500

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Classification Product Code OCV
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Date Received 02/21/2024
Decision Date 10/22/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
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 K240506


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