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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 K943117
Device Name INTRA-SONIX UROFIBER
Applicant
INTRA-SONIX, INC.
42 THIRD AVE.
BURLINGTON,  MA  01803
Applicant Contact DANIEL MCNULTY
Correspondent
INTRA-SONIX, INC.
42 THIRD AVE.
BURLINGTON,  MA  01803
Correspondent Contact DANIEL MCNULTY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/27/1994
Decision Date 08/04/1994
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
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