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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K930167
Device Name REUSABLE TOWEL AND GOWN PACKS
Applicant
Custom Sterile Services, Inc.
711 - 78th Ave. SW
Tumwater,  WA  98501
Applicant Contact ROD POWELL
Correspondent
Custom Sterile Services, Inc.
711 - 78th Ave. SW
Tumwater,  WA  98501
Correspondent Contact ROD POWELL
Regulation Number878.5070
Classification Product Code
FYD  
Date Received01/13/1993
Decision Date 11/30/1993
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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