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510(k) K890466

SIGMOID TONOMITOR by Tonometrics, Inc. — Product Code GBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1989
Date Received
January 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Rectal
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Tonometrics, Inc.

  • K920849 — TRIP CIC CATHETER (March 17, 1995)
  • K911825 — TRIP(TM) NASOGASTRIC SUMP CATHETER (July 23, 1991)
  • K883234 — TONOMITOR (TM) + SUMP (October 12, 1988)

Other clearances for product code GBT

  • K941391 — INFLATABLE RETENTION CUFF SPECULUM (October 20, 1994)
  • K924549 — TRI-MED QUICK-STEP(TM) RECTAL TUBE (February 10, 1994)