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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 K925290
Device Name CATALOG NUMBER 111 (FACESHIELD)
Applicant
Ansley Medical Products, Inc.
4201 Kellway Circle
Dallas,  TX  75244
Applicant Contact MIKE BOWEN
Correspondent
Ansley Medical Products, Inc.
4201 Kellway Circle
Dallas,  TX  75244
Correspondent Contact MIKE BOWEN
Regulation Number878.4040
Classification Product Code
LYU  
Subsequent Product Code
FXX  
Date Received10/21/1992
Decision Date 07/23/1993
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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