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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Finger Cot
510(k) Number K912042
Device Name BETHEL PLUS MULTIPLE NAMES
Applicant
Bethel Latex Products, Inc.
C/O Lowenkamp Intl., Inc.
P.O. Box 878
Haz;Ejirst,  MS  39083
Applicant Contact WILLIAM C LOWENKAMP
Correspondent
Bethel Latex Products, Inc.
C/O Lowenkamp Intl., Inc.
P.O. Box 878
Haz;Ejirst,  MS  39083
Correspondent Contact WILLIAM C LOWENKAMP
Regulation Number880.6250
Classification Product Code
LZB  
Date Received05/08/1991
Decision Date 07/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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