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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detectors And Removers, Lice, (Including Combs)
510(k) Number K822574
Device Name INNOMED PD-1 KIT
Applicant
Innomed Corp.
2629 Durant Oaks Dr.
Valrico,  FL  33594
Correspondent
Innomed Corp.
2629 Durant Oaks Dr.
Valrico,  FL  33594
Regulation Number880.5960
Classification Product Code
LJL  
Date Received08/24/1982
Decision Date 10/13/1982
Decision Substantially Equivalent (SESE)
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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