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510(k) K915739

#903 SILAFLEX II by Flents Products Co., Inc. — Product Code EWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1992
Date Received
December 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Hearing (Insert)
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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  • K862045 — DOC'S PROPLUGS EAR PLUGS (April 10, 1987)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)