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510(k) K963505

TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM by Tenet Medical Engineering — Product Code HHP

K963505 is an FDA 510(k) premarket notification submitted by Tenet Medical Engineering for the device "TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code HHP (Table, Obstetrical, Manual (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Tenet Medical Engineering has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1997
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Obstetrical, Manual (And Accessories)
Device Class
Class II
Regulation Number
884.4900
Review Panel
OB
Submission Type

Other clearances by Tenet Medical Engineering

  • K963506 — TENET RADIOLUCENT HAND TABLE (January 9, 1997)
  • K964102 — TENET TIBIAL FRACTURE SUPPORT (December 5, 1996)

Other clearances for product code HHP

  • K822812 — YSI MODEL 23L LACTATE ANALYZER (December 13, 1982)

FDA data resources