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510(k) K962292

HEARSAVER by Emtech Laboratories — Product Code EWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1996
Date Received
June 14, 1996
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

Other clearances by Emtech Laboratories

  • K853381 — OE SERIES OF BEHIND-THE-EAR HEARING AIDS (November 8, 1985)

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  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • K915739 — #903 SILAFLEX II (June 30, 1992)
  • K910177 — SEAL-RITE SILICONE EAR PLUG (June 24, 1991)
  • K862045 — DOC'S PROPLUGS EAR PLUGS (April 10, 1987)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)