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510(k) K910781

#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES by Midmark Corp. — Product Code ETF

K910781 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
February 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Examining/Treatment, Ent
Device Class
Class I
Regulation Number
874.5300
Review Panel
EN
Submission Type

Other clearances by Midmark Corp.

  • K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100C (January 7, 2013)
  • K120239 — ELEVANCE (August 24, 2012)
  • K112380 — CLEARVISION (November 22, 2011)
  • K091866 — PROGENY VANTAGE PANORAMIC X-RAY SYSTEM (July 20, 2009)
  • K090670 — MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (July 7, 2009)
  • K023348 — MIDMARK M9 ULTRACLAVE STEAM STERILIZER (March 3, 2003)
  • K003090 — MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (October 18, 2000)
  • K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER (January 10, 2000)
  • K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (April 19, 1999)
  • K936181 — MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (November 30, 1994)

Other clearances for product code ETF

  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K945395 — PREMIER MIRROR WARMER (January 18, 1995)
  • K932470 — LANGGASSE 90 (August 25, 1993)
  • K911901 — MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (July 26, 1991)
  • K910243 — MOBILE TREATMENT CART (April 17, 1991)
  • K896298 — JEDMED S CHAIR (January 26, 1990)
  • K896273 — SYSTEMA ENT CABINET (January 26, 1990)
  • K881958 — JEDMED MAXIM ENT CABINET (July 15, 1988)
  • K860940 — MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (May 2, 1986)
  • K855021 — LARYNGEAL MIRROR PRE-WARMER (March 20, 1986)

FDA data resources