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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name First Aid Kit With Drug
510(k) Number K964029
Device Name EMERGENCY RELIEF KIT SYSTEM
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Applicant Contact MARYALICE SMITH
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Correspondent Contact MARYALICE SMITH
Classification Product Code
LRR  
Date Received10/07/1996
Decision Date 03/17/1997
Decision Substantially Equivalent - Kit With Drugs (SEKD)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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