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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K960866
Device Name LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
Applicant
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact KIM E AVES
Correspondent
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact KIM E AVES
Regulation Number876.5130
Classification Product Code
KNY  
Date Received03/04/1996
Decision Date 04/05/1996
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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