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510(k) K944897

HOME CARE EAR EXAMINATIO KIT by Home Care Instruments, Inc. — Product Code ERA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1994
Date Received
October 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

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  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)