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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 K033249
Device Name PAJUNK MODULAR HANDLE INSTRUMENTS
Applicant
Pajunk GmbH
203 Main St.
Pmb 166
Flemington,  NJ  08822
Applicant Contact LYNETTE L HOWARD
Correspondent
Pajunk GmbH
203 Main St.
Pmb 166
Flemington,  NJ  08822
Correspondent Contact LYNETTE L HOWARD
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/07/2003
Decision Date 03/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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