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510(k) K913276

MICROTEK MEDICAL'S SOUND STIKS by Microbio-Medics, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
July 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Microbio-Medics, Inc.

  • K923353 — VENTILATION TUBES W/ HYDROGEL COATING (May 18, 1993)
  • K922572 — 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (November 2, 1992)
  • K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (June 21, 1991)
  • K910167 — MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (April 15, 1991)
  • K900726 — MICROTEK MEDICAL'S BLOOD COLLECTION KIT (May 4, 1990)
  • K901154 — MICROTEK'S SURGICAL LAMP HANDLE & COVER (March 20, 1990)
  • K895814 — MICROTEK PISTON & WIRE PROSTHESES (December 26, 1989)
  • K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS (December 26, 1989)
  • K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (December 8, 1989)
  • K885201 — OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT (April 19, 1989)

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