FDA 510(k) Application Details - K242803

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K242803
Device Name Unit, Cryosurgical, Accessories
Applicant Medtech Products Inc.
660 White Plains Road
Suite 250
Tarrytown, NY 10591 US
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Contact Vincent Argiro
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 09/17/2024
Decision Date 11/06/2024
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 K242803


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