Home / 510(k) Clearances / K910177

510(k) K910177

SEAL-RITE SILICONE EAR PLUG by Flents Products Co., Inc. — Product Code EWD

K910177 is an FDA 510(k) premarket notification submitted by Flents Products Co., Inc. for the device "SEAL-RITE SILICONE EAR PLUG". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Flents Products Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
January 15, 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

Other clearances by Flents Products Co., Inc.

  • K915739 — #903 SILAFLEX II (June 30, 1992)

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

FDA data resources