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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K854063
Device Name MICROVASIVE SILICONE SPRAY
Applicant
Microvasive
31 Maple St.
Milford,  MA  01757
Applicant Contact SAMUEL D WADE
Correspondent
Microvasive
31 Maple St.
Milford,  MA  01757
Correspondent Contact SAMUEL D WADE
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/04/1985
Decision Date 10/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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