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510(k) K944198

SURGICAL MICROSCOPE DRAPE by Hydro-Med Products, Inc. — Product Code MMP

K944198 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "SURGICAL MICROSCOPE DRAPE". The FDA issued a decision of Substantially Equivalent on November 27, 1994. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1994
Date Received
August 29, 1994
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 Hydro-Med Products, Inc.

  • K940151 — ULTRASOUND PROBE DRAPE (November 14, 1994)
  • K934630 — UNIVERSAL VIDEO/LASER ARM DRAPE (October 28, 1994)
  • K940152 — CAMERA COVER WITH TEAR TIP (October 28, 1994)
  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K853281 — EASYTOP (August 21, 1985)
  • K842304 — THE PATHFINDER (August 1, 1984)
  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)
  • K790659 — INFANT SCALE DISPOSABLE LINER (April 30, 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