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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K921976
Device Name FIRST AID KIT
Applicant
The Home Emergency Room
13334 Calle Colina
Poway,  CA  92064
Applicant Contact RAY POLIAKOFF
Correspondent
The Home Emergency Room
13334 Calle Colina
Poway,  CA  92064
Correspondent Contact RAY POLIAKOFF
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/27/1992
Decision Date 09/10/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
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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