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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 K011073
Device Name CRYOPLAN SYSTEM
Applicant
CRYOMEDICAL SCIENCES, INC.
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
CRYOMEDICAL SCIENCES, INC.
PO BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received04/09/2001
Decision Date 08/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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