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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K991830
Device Name CAPSULAR SHRINKAGE ELECTRODE
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact LAURA SENEFF
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact LAURA SENEFF
Regulation Number878.4400
Classification Product Code
JOS  
Date Received05/28/1999
Decision Date 08/20/1999
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
Recalls CDRH Recalls
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