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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 K953348
Device Name ARTICULATING RETRACTOR TISSUE RETRACTORS
Applicant
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Applicant Contact JARED K LARSEN
Correspondent
Gm Engineering, Inc.
2549 Sierra Way, Suite B
La Verne,  CA  91750
Correspondent Contact JARED K LARSEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/17/1995
Decision Date 09/12/1995
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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