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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K900370
Device Name ONE/CIRC (CIRCUMCISION CLAMP)
Applicant
BIONIX DEVELOPMENT CORP.
757 WAREHOUSE RD. STE.G
TOLEDO,  OH  43615
Applicant Contact HUTTNER, MD
Correspondent
BIONIX DEVELOPMENT CORP.
757 WAREHOUSE RD. STE.G
TOLEDO,  OH  43615
Correspondent Contact HUTTNER, MD
Regulation Number884.4530
Classification Product Code
HFX  
Date Received01/25/1990
Decision Date 04/16/1990
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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