FDA 510(k) Application Details - K021387

Device Classification Name Unit, Cryosurgical, Accessories

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510(K) Number K021387
Device Name Unit, Cryosurgical, Accessories
Applicant CHEK-MED SYSTEMS
25 VILLAGE HILL RD.
WILLINGTON, CT 06279 US
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Contact ROB WHALEN
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Regulation Number 878.4350

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Classification Product Code GEH
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Date Received 05/02/2002
Decision Date 07/31/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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