FDA 510(k) Application Details - K130599

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K130599
Device Name Unit, Cryosurgical, Accessories
Applicant KONINKLIJKE UTERMOHLEN NV
11956 BERNARDO PLAZA DR.
#417
SAN DIEGO, CA 92128-1317 US
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Contact KENNETH R MICHAEL
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 03/07/2013
Decision Date 06/05/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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