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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 K925267
Device Name GRASPING FORCEPS OR RETRIEVAL FORCEPS
Applicant
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Applicant Contact STUART J LIND
Correspondent
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Correspondent Contact STUART J LIND
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/19/1992
Decision Date 02/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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