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510(k) K771615

AUDI-SIL EARMOLD MATERIAL by Coe Laboratories, Inc. — Product Code ESH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1977
Date Received
August 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

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