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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K024009
Device Name CRYOPROBE
Applicant
H&O Equipments, Nv/Sa
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
H&O Equipments, Nv/Sa
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number878.4350
Classification Product Code
GEH  
Date Received12/04/2002
Decision Date 03/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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