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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, Inflatable, External
510(k) Number K874052
Device Name INFLATABLE HALF LEG SPLINT
Applicant
Vinyl Technology, Inc.
2110 Edwards Ave.
So. El Monte,  CA  91733
Applicant Contact CARLOS A MOLLURA
Correspondent
Vinyl Technology, Inc.
2110 Edwards Ave.
So. El Monte,  CA  91733
Correspondent Contact CARLOS A MOLLURA
Regulation Number878.3900
Classification Product Code
FZF  
Date Received10/05/1987
Decision Date 11/23/1987
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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