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510(k) K821187

MEDCO CUSTOM EAR PROTECTOR MOLD KIT by Santa Barbara Medco, Inc. — Product Code EWD

K821187 is an FDA 510(k) premarket notification submitted by Santa Barbara Medco, Inc. for the device "MEDCO CUSTOM EAR PROTECTOR MOLD KIT". The FDA issued a decision of Substantially Equivalent on May 27, 1982. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Santa Barbara Medco, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
April 27, 1982
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 Santa Barbara Medco, Inc.

  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K842483 — SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC (August 31, 1984)
  • K823921 — PHYSICIANS CHOICE SILICONE EAR PUTTY (March 28, 1983)
  • K812069 — BORES* DEPTH GAUGE (August 31, 1981)
  • K812071 — RK IV SURGICAL BLADES (August 31, 1981)
  • K812070 — BORES* ADJUSTABLE BLADE HOLDER (August 18, 1981)
  • K802638 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

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