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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 K954382
Device Name PROLASTIC SHEETING
Applicant
PILLAR SURGICAL
1444 RODEO DR.
LA JOLLA,  CA  92037
Applicant Contact ROB FRITZENKOTTER
Correspondent
PILLAR SURGICAL
1444 RODEO DR.
LA JOLLA,  CA  92037
Correspondent Contact ROB FRITZENKOTTER
Regulation Number874.3620
Classification Product Code
MIB  
Date Received09/19/1995
Decision Date 11/29/1995
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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