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510(k) K820692

BANDBAG, WRAP, STERILE by Contour Fabricators, Inc. — Product Code MMP

K820692 is an FDA 510(k) premarket notification submitted by Contour Fabricators, Inc. for the device "BANDBAG, WRAP, STERILE". The FDA issued a decision of Substantially Equivalent on May 3, 1982. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Contour Fabricators, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1982
Date Received
March 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Contour Fabricators, Inc.

  • K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
  • K970900 — INSTRUMENT HOLDER (May 22, 1997)
  • K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
  • K970185 — STERILE DISPOSABLE EQUIPMENT MAGNET COVER (April 10, 1997)
  • K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
  • K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
  • K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)

FDA data resources