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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K922126
Device Name HOSPITAL KIT ENT 1125
Applicant
Savoy Medical Supply Co., Inc.
99 W. Hawthorne Ave.
Valley Stream,  NY  11580
Applicant Contact GUY SAVIA
Correspondent
Savoy Medical Supply Co., Inc.
99 W. Hawthorne Ave.
Valley Stream,  NY  11580
Correspondent Contact GUY SAVIA
Regulation Number878.4800
Classification Product Code
LRP  
Date Received05/06/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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