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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(k) Number K013113
Device Name MODIFICATION TO NANMA VACUUM PUMP
Applicant
Nanma Mfg Co., Ltd.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact YOLANDA SMITH
Correspondent
Nanma Mfg Co., Ltd.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact YOLANDA SMITH
Regulation Number876.5020
Classification Product Code
LKY  
Date Received09/18/2001
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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