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510(k) K822370

UNIVERSAL SPECULUM HOLDER by Treace Medical, Inc. — Product Code EPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1982
Date Received
August 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
Submission Type

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  • K870759 — CLEANING SOLUTION, CATALOG NO. 8203 (May 7, 1987)
  • K870766 — PROSTHESIS WIRE (April 15, 1987)
  • K870764 — SCHUKNECHT WIRE CUTTING SCISSORS (March 18, 1987)

Other clearances for product code EPY

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  • K791123 — EAR AND NOSE SPECULA (July 10, 1979)
  • K780723 — OTOSCOPE SPECULA (May 9, 1978)
  • K772370 — BARRAQUER OVAL SPECULUM-VARIOUS SIZES (January 17, 1978)
  • K772380 — FARRIOR OVAL SPECULUM (January 17, 1978)