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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name airbrush
510(k) Number K984380
Device Name DISPO ETCH
Applicant
KIS PRODUCTS
2318 SEA ISLAND DR.
FT. LAUDERDALE,  FL  33301
Applicant Contact REUBEN HERTZ
Correspondent
KIS PRODUCTS
2318 SEA ISLAND DR.
FT. LAUDERDALE,  FL  33301
Correspondent Contact REUBEN HERTZ
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received12/08/1998
Decision Date 08/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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