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510(k) K791608

BILSOM PROPP by Bilson International, Inc. — Product Code EWD

K791608 is an FDA 510(k) premarket notification submitted by Bilson International, Inc. for the device "BILSOM PROPP". The FDA issued a decision of Substantially Equivalent on October 10, 1979. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1979
Date Received
August 13, 1979
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 for product code EWD

  • K020296 — ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (June 25, 2002)
  • K972923 — SUPER SILIPLUGS EAR PLUGS (October 27, 1997)
  • K971517 — SILICONE PUTTY EAR PLUGS (June 2, 1997)
  • K962292 — HEARSAVER (October 29, 1996)
  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • 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)

FDA data resources