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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 K994319
Device Name MODULAP
Applicant
ATC TECHNOLOGIES, INC.
1034 LINCOLN ST.
HOLLYWOOD,  FL  33019
Applicant Contact MARIAN HARDING COCHRAN
Correspondent
ATC TECHNOLOGIES, INC.
1034 LINCOLN ST.
HOLLYWOOD,  FL  33019
Correspondent Contact MARIAN HARDING COCHRAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/22/1999
Decision Date 03/20/2000
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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