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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 K922716
Device Name SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
Applicant
Splash Shield, Inc.
52 Dragon Ct.
Woburn,  MA  01801
Applicant Contact BUKE, JR.
Correspondent
Splash Shield, Inc.
52 Dragon Ct.
Woburn,  MA  01801
Correspondent Contact BUKE, JR.
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/05/1992
Decision Date 10/23/1992
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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