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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Articulators
510(k) Number K926190
Device Name ALRAND INC. (DENTAL HAND INSTRUMENTS)
Applicant
Alrand, Inc.
829 E. Palmetto Park Rd.
Boca Raton,  FL  33432
Applicant Contact ALVARO BETANCUR
Correspondent
Alrand, Inc.
829 E. Palmetto Park Rd.
Boca Raton,  FL  33432
Correspondent Contact ALVARO BETANCUR
Regulation Number872.3150
Classification Product Code
EJP  
Date Received12/09/1992
Decision Date 01/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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