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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K961407
Device Name SPEED-CUT
Applicant
Gallini Intl., Inc.
200 Winston Dr., Apt. L-11
Cliffside Park,  NJ  07010
Applicant Contact CATERINA ELENA GALLUZZO
Correspondent
Gallini Intl., Inc.
200 Winston Dr., Apt. L-11
Cliffside Park,  NJ  07010
Correspondent Contact CATERINA ELENA GALLUZZO
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/11/1996
Decision Date 11/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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