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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K992436
Device Name GOWN BACK, MODEL 13-403N; 13-404N; 13-405N
Applicant
Techstyles
16415 Addison Rd., #850
Addison,  TX  75001
Applicant Contact STEPHANIE T HOWARD
Correspondent
Techstyles
16415 Addison Rd., #850
Addison,  TX  75001
Correspondent Contact STEPHANIE T HOWARD
Regulation Number878.4040
Classification Product Code
FYA  
Date Received07/22/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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