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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 K042740
Device Name ISC-1000 PENTAX CONFOCAL LASER SYSTEM
Applicant
Pentax Medical Company
102 Chestnut Ridge Rd.
Montvale,  NJ  07645
Applicant Contact PAUL SILVA
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
FDF  
Date Received10/04/2004
Decision Date 10/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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