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510(k) K905003

BIO-GUARD SHAVE PREP TRAY by Network Medical Systems, Inc. — Product Code KME

K905003 is an FDA 510(k) premarket notification submitted by Network Medical Systems, Inc. for the device "BIO-GUARD SHAVE PREP TRAY". The FDA issued a decision of Substantially Equivalent (kit) on December 28, 1990. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Network Medical Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 28, 1990
Date Received
November 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

Other clearances by Network Medical Systems, Inc.

  • K921664 — BIO-GUARD LATEX SURGICAL GLOVES (September 23, 1992)
  • K905004 — BIO-GUARD O.R. SCRUB PREP TRAY (February 21, 1991)

Other clearances for product code KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)

FDA data resources