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510(k) K792721

HUESTIS FLEXI-HOLDER by Huestis Machine Corp. — Product Code IXA

K792721 is an FDA 510(k) premarket notification submitted by Huestis Machine Corp. for the device "HUESTIS FLEXI-HOLDER". The FDA issued a decision of Substantially Equivalent on Feb 19, 1980. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Huestis Machine Corp. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 19, 1980
Date Received
Dec 31, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type
510(k) Exempt

Other clearances by Huestis Machine Corp.

  • K940145 — COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE (Jan 24, 1995)
  • K926187 — POSICAST IMMOBILIZATION SYSTEM (Apr 15, 1994)
  • K904005 — HUESTIS FLEXI-BOARD (Nov 29, 1990)
  • K901567 — THE HUESTIS COMPU-PLOTTER (May 31, 1990)
  • K880047 — HUESTIS COMPU-FORMER (Apr 11, 1988)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (Sep 10, 2008)
  • K053173 — DS CASSETTE (Dec 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX… (Sep 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (Jul 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (Dec 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (Oct 12, 2001)
  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (Aug 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (Mar 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (Mar 23, 1998)

FDA data resources