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510(k) K791123

EAR AND NOSE SPECULA by Xomed, Inc. — Product Code EPY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1979
Date Received
June 15, 1979
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

Other clearances by Xomed, Inc.

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  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code EPY

  • K950086 — PEDIA PALS, INCORPORATED (February 7, 1995)
  • K925754 — ECONOM (October 8, 1993)
  • K853588 — FIBRELIGHT NASAL SPECULA (December 18, 1985)
  • K834189 — JAKOBI SURG. INSTRUMENTS #7 44/47 (March 6, 1984)
  • K822373 — EAR SURGERY SPECULUM (September 9, 1982)
  • K822370 — UNIVERSAL SPECULUM HOLDER (September 9, 1982)
  • K822164 — EAR SPECULI (August 11, 1982)
  • K780723 — OTOSCOPE SPECULA (May 9, 1978)
  • K772370 — BARRAQUER OVAL SPECULUM-VARIOUS SIZES (January 17, 1978)
  • K772380 — FARRIOR OVAL SPECULUM (January 17, 1978)