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510(k) K964102

TENET TIBIAL FRACTURE SUPPORT by Tenet Medical Engineering — Product Code GBB

K964102 is an FDA 510(k) premarket notification submitted by Tenet Medical Engineering for the device "TENET TIBIAL FRACTURE SUPPORT". The FDA issued a decision of Substantially Equivalent on December 5, 1996. The device falls under product code GBB (Chair, Surgical, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Tenet Medical Engineering has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1996
Date Received
October 11, 1996
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 Tenet Medical Engineering

  • K963505 — TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM (February 14, 1997)
  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)

Other clearances for product code GBB

  • K893598 — HYDRAULIC FOOT OPERATED STOOL (October 10, 1989)
  • K831385 — LITHOTOMY CHAIR #415 (June 2, 1983)
  • 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