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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 K875068
Device Name AIDS SAFETY BELT
Applicant
Aids Safety Belt, Inc.
2221 Orange Blssm Ln.
Bradenton,  FL  33507
Applicant Contact HERMAN THOMAS
Correspondent
Aids Safety Belt, Inc.
2221 Orange Blssm Ln.
Bradenton,  FL  33507
Correspondent Contact HERMAN THOMAS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/08/1987
Decision Date 05/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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