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510(k) K831385

LITHOTOMY CHAIR #415 by Midmark Corp. — Product Code GBB

K831385 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "LITHOTOMY CHAIR #415". The FDA issued a decision of Substantially Equivalent on June 2, 1983. The device falls under product code GBB (Chair, Surgical, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1983
Date Received
April 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Surgical, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
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 GBB

  • K964102 — TENET TIBIAL FRACTURE SUPPORT (December 5, 1996)
  • K893598 — HYDRAULIC FOOT OPERATED STOOL (October 10, 1989)
  • K831325 — NUTROMAT (June 2, 1983)
  • K822264 — NAGASHIMA SN OPERATOR'S CHAIR (October 13, 1982)
  • K822251 — EXAMINATION & TREATMENT CHAIRS (August 27, 1982)
  • K822013 — NAGASHIMA SN AUTOMATIC TREATMENT CHAIR (July 28, 1982)
  • K820636 — STORZ #6500 POWER EXAMINATION CHAIR (March 26, 1982)

FDA data resources