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510(k) K020296

ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 by Apothecary Products, Inc. — Product Code EWD

K020296 is an FDA 510(k) premarket notification submitted by Apothecary Products, Inc. for the device "ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057". The FDA issued a decision of Substantially Equivalent on June 25, 2002. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Apothecary Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2002
Date Received
January 28, 2002
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 Apothecary Products, Inc.

  • K140409 — FLENTS PLASTIC EYE WASH CUP (July 9, 2014)
  • K111856 — SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS C (July 14, 2011)
  • K041766 — EZY-TRAVEL WRISTBAND (November 26, 2004)
  • K892242 — PATIENT EXAMINATION GLOVES (LATEX) (May 12, 1989)
  • K833311 — NITROGLYCERINE CONTAINER (February 4, 1984)

Other clearances for product code EWD

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

FDA data resources