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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 K922243
Device Name E-Z CLAMP#1 AND#2
Applicant
Southwest Medical Mfg., Inc.
P.O. Box 71261
Marietta,  GA  30007
Applicant Contact MICHAEL C SIBLEY
Correspondent
Southwest Medical Mfg., Inc.
P.O. Box 71261
Marietta,  GA  30007
Correspondent Contact MICHAEL C SIBLEY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/13/1992
Decision Date 07/14/1992
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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