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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K955183
Device Name SAFE KNIGHTS
Applicant
L & N CORP.
83 AMES ST.
BROCKTON,  MA  02402
Applicant Contact DAN NGUYEN
Correspondent
L & N CORP.
83 AMES ST.
BROCKTON,  MA  02402
Correspondent Contact DAN NGUYEN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/13/1995
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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