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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 K854767
Device Name LM 1000
Applicant
Leisegang Medical, Inc.
8801 SW 129 St.
Miami,  FL  33176
Applicant Contact DOUGLAS KWART
Correspondent
Leisegang Medical, Inc.
8801 SW 129 St.
Miami,  FL  33176
Correspondent Contact DOUGLAS KWART
Regulation Number878.4350
Classification Product Code
GEH  
Date Received11/27/1985
Decision Date 01/24/1986
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
Predetermined Change
Control Plan Authorized		 No
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