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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K920217
Device Name MAX-E-VAC
Applicant
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Applicant Contact DOUGLAS KWART
Correspondent
Leisegang Medical, Inc.
6401 Congress Ave.
Boca Raton,  FL  33487
Correspondent Contact DOUGLAS KWART
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/16/1992
Decision Date 07/23/1992
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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