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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K871616
Device Name CUSTOM PROCEDURE TRAYS
Applicant
Medical Custom Products, Inc.
246 Dodge Ave.
P.O. Box 567
East Haven,  CT  06512
Applicant Contact DORSIE W MARCUM
Correspondent
Medical Custom Products, Inc.
246 Dodge Ave.
P.O. Box 567
East Haven,  CT  06512
Correspondent Contact DORSIE W MARCUM
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/27/1987
Decision Date 12/11/1987
Decision Substantially Equivalent - With Drug (SESD)
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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