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510(k) K932319

ORTHODONTIC ELASTOMER by Gac Intl., Inc. — Product Code ECI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1993
Date Received
May 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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