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510(k) K823921

PHYSICIANS CHOICE SILICONE EAR PUTTY by Santa Barbara Medco, Inc. — Product Code LDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1983
Date Received
December 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Earmold, Impression
Device Class
Class I
Regulation Number
874.3300
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)
  • 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)

Other clearances for product code LDG

  • K792428 — COE-SIL (January 23, 1980)