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510(k) K901426

COLONIC BALLOON DILATOR by Telemed Systems, Inc. — Product Code FFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1990
Date Received
March 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Rectal
Device Class
Class I
Regulation Number
876.5450
Review Panel
GU
Submission Type

Other clearances by Telemed Systems, Inc.

  • K020379 — PPD BALLOON DILATATION CATHETER (May 6, 2002)
  • K013737 — MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (March 1, 2002)
  • K010412 — FLEXIBLE ENDOSCOPIC SCISSORS (April 2, 2001)
  • K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM (December 22, 1999)
  • K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 (December 22, 1999)
  • K974312 — REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUS (January 21, 1998)
  • K974300 — TELEMED SYSTEMS RETRIEVAL BASKET (December 19, 1997)
  • K901435 — GASTROINTESTINAL CYTOLOGY BRUSH (July 16, 1990)
  • K901427 — BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON (June 22, 1990)
  • K901433 — SURE-FLEX ANASTOMOTIC BALLOON DILATOR (June 21, 1990)

Other clearances for product code FFP

  • K964634 — ANOKRYO (June 6, 1997)
  • K894618 — INAMED RHEMO-D (TM) DILATOR (January 18, 1990)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K830354 — COLORECTAL DILATOR (May 27, 1983)