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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K003102
Device Name PARE ENDOSCOPIC SUTURING SYSTEM
Applicant
Pare Surgical, Inc.
7332 S. Alton Way, Unit H
Englewood,  CO  80112
Applicant Contact RICHARD P FLEENOR
Correspondent
Pare Surgical, Inc.
7332 S. Alton Way, Unit H
Englewood,  CO  80112
Correspondent Contact RICHARD P FLEENOR
Regulation Number876.1500
Classification Product Code
OCW  
Date Received10/04/2000
Decision Date 02/27/2001
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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