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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 K945520
Device Name HEMOCLIP ECOSYSTEM
Applicant
Pilling Weck, Inc.
One Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Applicant Contact PONZELLE ROYSTER
Correspondent
Pilling Weck, Inc.
One Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Correspondent Contact PONZELLE ROYSTER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/10/1994
Decision Date 01/27/1995
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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