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510(k) K231672

S1 by Medpark Co., Ltd. — Product Code NPM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2023
Date Received
June 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Animal Source
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

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