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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K933827
Device Name BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS
Applicant
BIOPLEXUS CORP.
3753 HOWARD HUGHES PKWY.
SUITE 310
LAS VEGAS,  NV  89109
Applicant Contact C.S. ESCHBACH
Correspondent
BIOPLEXUS CORP.
3753 HOWARD HUGHES PKWY.
SUITE 310
LAS VEGAS,  NV  89109
Correspondent Contact C.S. ESCHBACH
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
MIB  
Date Received08/05/1993
Decision Date 06/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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