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510(k) K842483

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

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.

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  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)
  • K812071 — RK IV SURGICAL BLADES (August 31, 1981)
  • K812069 — BORES* DEPTH GAUGE (August 31, 1981)
  • K812070 — BORES* ADJUSTABLE BLADE HOLDER (August 18, 1981)
  • K802638 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

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