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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Orthodontic
510(k) Number K896586
Device Name RATE INCREASE FOR IPPB/IPV
Applicant
Percussionaire Corp.
Bird Airlodge, Glengary Bay
P.O. Box 817
Sandpoint,  ID  83864
Applicant Contact BIRD, MD
Correspondent
Percussionaire Corp.
Bird Airlodge, Glengary Bay
P.O. Box 817
Sandpoint,  ID  83864
Correspondent Contact BIRD, MD
Regulation Number872.5410
Classification Product Code
DZD  
Date Received11/22/1989
Decision Date 01/09/1990
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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