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510(k) K850544

SHAVE PREP TRAY by Packaging Technologies, Inc. — Product Code KME

K850544 is an FDA 510(k) premarket notification submitted by Packaging Technologies, Inc. for the device "SHAVE PREP TRAY". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Packaging Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
February 12, 1985
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 Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K863326 — BONE MARROW TRAY (September 16, 1986)
  • K861041 — ENHANCE (May 30, 1986)
  • K850438 — RENAL BIOPSY TRAY (February 26, 1985)
  • K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
  • K844614 — IV START KIT (December 19, 1984)
  • K844611 — SINGLE BASIN SET (December 19, 1984)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)
  • K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

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