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510(k) K842483

SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC by Santa Barbara Medco, Inc. — Product Code EGJ

K842483 is an FDA 510(k) premarket notification submitted by Santa Barbara Medco, Inc. for the device "SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC". The FDA issued a decision of Substantially Equivalent on August 31, 1984. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Santa Barbara Medco, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1984
Date Received
June 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Santa Barbara Medco, Inc.

  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K823921 — PHYSICIANS CHOICE SILICONE EAR PUTTY (March 28, 1983)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)
  • 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 EGJ

  • K242041 — STOPWET iontophoresis apparatus (SW01) (April 1, 2025)
  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • K192749 — Dermadry (February 10, 2020)
  • K191436 — Saalio (October 18, 2019)
  • K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant (June 15, 2018)
  • K170291 — IontoDC (May 1, 2017)
  • K150453 — TULA Iontophoresis System with Earset (May 20, 2015)
  • K133033 — HIDREX PSP1000 (April 8, 2015)
  • K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCH (February 13, 2014)

FDA data resources