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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 K091440
Device Name LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
Applicant
Bovie Medical
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact RICHARD KOZLOFF
Correspondent
Bovie Medical
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact RICHARD KOZLOFF
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/15/2009
Decision Date 10/09/2009
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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