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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 K041131
Device Name APPLE MEDICAL OB 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
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/30/2004
Decision Date 05/13/2004
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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