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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K925815
Device Name REUSABLE LIQUIDPROOF BOOTIE
Applicant
Amsco Sterile Recoveries, Inc.
28100 U.S. Hwy., 19n., Suite 201
Clearwater,  FL  34621
Applicant Contact DENISE A SCHOTTLER
Correspondent
Amsco Sterile Recoveries, Inc.
28100 U.S. Hwy., 19n., Suite 201
Clearwater,  FL  34621
Correspondent Contact DENISE A SCHOTTLER
Regulation Number878.4040
Classification Product Code
FXP  
Subsequent Product Codes
FXW   LYU  
Date Received11/17/1992
Decision Date 07/09/1993
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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