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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 K942597
Device Name CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR
Applicant
Holmed Corp.
40 Norfolk Ave.
South Easton,  MA  02375
Applicant Contact RUSSELL HOLMES
Correspondent
Holmed Corp.
40 Norfolk Ave.
South Easton,  MA  02375
Correspondent Contact RUSSELL HOLMES
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/1994
Decision Date 08/15/1994
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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