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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 K863507
Device Name PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS
Applicant
Physician & Nurses Mfg. Corp.
P.O. Box 68
Larchmont,  NY  10538
Applicant Contact JAMES D HOGAN
Correspondent
Physician & Nurses Mfg. Corp.
P.O. Box 68
Larchmont,  NY  10538
Correspondent Contact JAMES D HOGAN
Regulation Number890.5710
Classification Product Code
IMD  
Date Received09/09/1986
Decision Date 09/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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