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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 K901667
Device Name LATEX CONDOMS - CODE NO. 401, 421 & 1002
Applicant
ALLERCARE/NSL, INC.
7150 N. RIDGEWAY
LINCOLNWOOD,  IL  60645
Applicant Contact FRANK J GOLDBERG
Correspondent
ALLERCARE/NSL, INC.
7150 N. RIDGEWAY
LINCOLNWOOD,  IL  60645
Correspondent Contact FRANK J GOLDBERG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/10/1990
Decision Date 05/16/1990
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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