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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Disposable
510(k) Number K970399
Device Name KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
Applicant
Allegiance Healthcare Corp.
1660 Iowa Ave., Suite 100/200
Riverside,  CA  92507
Applicant Contact MARYALICE SMITH
Correspondent
Allegiance Healthcare Corp.
1660 Iowa Ave., Suite 100/200
Riverside,  CA  92507
Correspondent Contact MARYALICE SMITH
Regulation Number890.5710
Classification Product Code
IMD  
Date Received02/03/1997
Decision Date 04/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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