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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K122875
Device Name ORICARE L2700
Applicant
ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN,  PA  18951
Applicant Contact DAVID T JAMISON
Correspondent
ORICARE, INC.
1900 AM DRIVE
QUAKERTOWN,  PA  18951
Correspondent Contact DAVID T JAMISON
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/19/2012
Decision Date 12/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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