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510(k) K971517

SILICONE PUTTY EAR PLUGS by Bentec Medical, Inc. — Product Code EWD

K971517 is an FDA 510(k) premarket notification submitted by Bentec Medical, Inc. for the device "SILICONE PUTTY EAR PLUGS". The FDA issued a decision of Substantially Equivalent on June 2, 1997. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Bentec Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1997
Date Received
April 25, 1997
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 Bentec Medical, Inc.

  • K002650 — VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 (February 16, 2001)
  • K971411 — DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CAT (June 3, 1997)

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)
  • 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)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)

FDA data resources