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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K844067
Device Name VANISH ORTHODONTIC BRACKET
Applicant
A Company, Inc.
11436 Sorrento Valley Rd.
Post Office Box 81247
San Diego,  CA  92138
Applicant Contact JOSEPH R MONFREDO
Correspondent
A Company, Inc.
11436 Sorrento Valley Rd.
Post Office Box 81247
San Diego,  CA  92138
Correspondent Contact JOSEPH R MONFREDO
Regulation Number872.5410
Classification Product Code
EJF  
Date Received10/18/1984
Decision Date 11/23/1984
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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