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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 K931144
Device Name STERILE SURGEON'S GOWN, MODIFICATION
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
FYA  
Date Received03/05/1993
Decision Date 06/10/1994
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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