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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
Predetermined Change
Control Plan Authorized		 No
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