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510(k) K082276

SYNTHEMED DEVICE by Synthemed, Inc. — Product Code LYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2008
Date Received
August 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

Other clearances by Synthemed, Inc.

  • K812464 — SYNTHEMED PULSE GENERATOR VVI MODEL 1000 (November 16, 1981)

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