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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Nipple
510(k) Number K864176
Device Name GENTLE FEEL
Applicant
MALI, INC.
18455 BURBACK BLVD, STE 411
TARZANA,  CA  91356
Applicant Contact CAROLE HIRSCH
Correspondent
MALI, INC.
18455 BURBACK BLVD, STE 411
TARZANA,  CA  91356
Correspondent Contact CAROLE HIRSCH
Regulation Number880.5630
Classification Product Code
HFS  
Date Received10/24/1986
Decision Date 11/04/1986
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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