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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K971917
Device Name KENTRON'S ISOLATION GOWN
Applicant
Kentron Health Care, Inc.
3604 Kelton Jackson Rd.
Springfield,  TN  37172
Applicant Contact NARI SADARANGANI
Correspondent
Kentron Health Care, Inc.
3604 Kelton Jackson Rd.
Springfield,  TN  37172
Correspondent Contact NARI SADARANGANI
Regulation Number878.4040
Classification Product Code
FYC  
Date Received05/23/1997
Decision Date 09/19/1997
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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