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510(k) K862045

DOC'S PROPLUGS EAR PLUGS by Doc'S Proplugs, Inc. — Product Code EWD

K862045 is an FDA 510(k) premarket notification submitted by Doc'S Proplugs, Inc. for the device "DOC'S PROPLUGS EAR PLUGS". The FDA issued a decision of Substantially Equivalent on April 10, 1987. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Doc'S Proplugs, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1987
Date Received
May 28, 1986
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 Doc'S Proplugs, Inc.

  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)

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

FDA data resources