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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K931042
Device Name MOORE SECURE CAP
Applicant
Kerma Medical Products, Inc.
1801-P Sara Dr.
Chesapeake,  VA  23320
Applicant Contact TONY ELLISON
Correspondent
Kerma Medical Products, Inc.
1801-P Sara Dr.
Chesapeake,  VA  23320
Correspondent Contact TONY ELLISON
Regulation Number878.4040
Classification Product Code
LYU  
Date Received03/01/1993
Decision Date 04/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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