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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K873731
Device Name SAFETY SHIELD KIT
Applicant
Ballard Medical Products
2101 L St. NW
Washington,  DC  20037
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Ballard Medical Products
2101 L St. NW
Washington,  DC  20037
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/10/1987
Decision Date 01/15/1988
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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