FDA 510(k) Application Details - K091721

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K091721
Device Name Unit, Cryosurgical, Accessories
Applicant NEW MEDICAL TECHNOLOGIES GMBH
1710 ROMANO DRIVE
PLYMOUTH MEETING, PA 19462 US
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Contact VINCE D'ALESSANDRO
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 06/11/2009
Decision Date 10/02/2009
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



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