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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K983623
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 Number876.1500
Classification Product Code
GCJ  
Date Received10/15/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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