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510(k) K895814

MICROTEK PISTON & WIRE PROSTHESES by Microbio-Medics, Inc. — Product Code ETB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1989
Date Received
September 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Partial Ossicular Replacement
Device Class
Class II
Regulation Number
874.3450
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)
  • K913276 — MICROTEK MEDICAL'S SOUND STIKS (October 21, 1991)
  • 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)
  • 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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