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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K922130
Device Name HOSPITAL KIT DK 117
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 Number878.4800
Classification Product Code
MDM  
Date Received05/06/1992
Decision Date 05/24/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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