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510(k) K895084

APERTURE by Custom Medical Products, Ltd. — Product Code IZS

K895084 is an FDA 510(k) premarket notification submitted by Custom Medical Products, Ltd. for the device "APERTURE". The FDA issued a decision of Substantially Equivalent on October 27, 1989. The device falls under product code IZS (Aperture, Radiographic), a Class II device regulated under 21 CFR 892.1610. Custom Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
August 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aperture, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances by Custom Medical Products, Ltd.

  • K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCED (June 9, 2000)
  • K931417 — STERILE EQUIPMENT COVERS (July 6, 1995)
  • K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
  • K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
  • K931418 — SURGICAL DRAPE (May 5, 1994)
  • K931455 — HEAD SHEET (May 5, 1994)
  • K931844 — CUSTOM PROCEDURE MEDICAL TRAY OR KIT (January 25, 1994)
  • K926519 — SURGICAL GOWN (August 12, 1993)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)

FDA data resources