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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K851906
Device Name SURGICAL EYE PACK
Applicant
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Applicant Contact DAVID B VANCE
Correspondent
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Correspondent Contact DAVID B VANCE
Regulation Number878.4440
Classification Product Code
HMP  
Date Received05/01/1985
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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