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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 K014005
Device Name APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
Applicant
Apple Medical Corp.
28 Lord Rd., Unit 135
Marlboro,  MA  01752
Applicant Contact JOHN C PULFORD
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/05/2001
Decision Date 02/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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