Home / 510(k) Clearances / K823921

510(k) K823921

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

K823921 is an FDA 510(k) premarket notification submitted by Santa Barbara Medco, Inc. for the device "PHYSICIANS CHOICE SILICONE EAR PUTTY". The FDA issued a decision of Substantially Equivalent on March 28, 1983. The device falls under product code LDG (Kit, Earmold, Impression), a Class I device regulated under 21 CFR 874.3300. Santa Barbara Medco, Inc. has at least 7 other 510(k) clearances on record.

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)
  • 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 LDG

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

FDA data resources