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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Clamp, Vascular
510(k) Number K802244
Device Name VESSEL RETRACTOR, #600732
Applicant
Bentley Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bentley Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/16/1980
Decision Date 10/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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