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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K952732
Device Name MEDICAL GRADE SILICONE BLOCK
Applicant
Bioplexus Corp.
3753 Howard Hughes Pkwy.,
Suite #310
Las Vegas,  NV  89109
Applicant Contact JEFF S SCHLEUNING
Correspondent
Bioplexus Corp.
3753 Howard Hughes Pkwy.,
Suite #310
Las Vegas,  NV  89109
Correspondent Contact JEFF S SCHLEUNING
Regulation Number874.3620
Classification Product Code
MIB  
Date Received06/15/1995
Decision Date 08/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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