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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 K953123
Device Name QUIK-STITCH
Applicant
Coral Medical, Inc.
5765 S. Monaco St.
Englewood,  CO  80111
Applicant Contact RICHARD P FLEENOR
Correspondent
Coral Medical, Inc.
5765 S. Monaco St.
Englewood,  CO  80111
Correspondent Contact RICHARD P FLEENOR
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/05/1995
Decision Date 09/08/1995
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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