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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Noninflatable, External, Sterile
510(k) Number K843400
Device Name HYDRO-SPLINT A SPONGE-COMPRESS DRESS
Applicant
Compression Splint Products, Inc.
P.O. Box 7407
Pittsburgh,  P  15213
Applicant Contact TONY I INVORVAIA
Correspondent
Compression Splint Products, Inc.
P.O. Box 7407
Pittsburgh,  P  15213
Correspondent Contact TONY I INVORVAIA
Regulation Number878.3910
Classification Product Code
FYH  
Date Received08/30/1984
Decision Date 10/24/1984
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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