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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K922133
Device Name HOSPITAL KIT SV 105
Applicant
Savoy Medical Supply Co., Inc.
745 Calebs Path
Hauppauge,  NY  11788
Applicant Contact GUY SAVIA
Correspondent
Savoy Medical Supply Co., Inc.
745 Calebs Path
Hauppauge,  NY  11788
Correspondent Contact GUY SAVIA
Regulation Number878.4370
Classification Product Code
LRO  
Date Received05/06/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit (SESK)
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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