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510(k) K872868

ASPEN ESMARK BANDAGE by Aspen Laboratories, Inc. — Product Code FQM

K872868 is an FDA 510(k) premarket notification submitted by Aspen Laboratories, Inc. for the device "ASPEN ESMARK BANDAGE". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Aspen Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1987
Date Received
July 21, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Elastic
Device Class
Class I
Regulation Number
880.5075
Review Panel
HO
Submission Type

Other clearances by Aspen Laboratories, Inc.

  • K981220 — SYSTEM 7500 ABC ELECTROSURGICAL UNIT (April 21, 1998)
  • K963088 — SHEATH, ELECTROSURGICAL PENCIL (September 13, 1996)
  • K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT (July 11, 1996)
  • K960296 — 4000 ETM (February 20, 1996)
  • K953081 — BEAMER PLUS (October 30, 1995)
  • K953007 — EXCALIBUR PLUS ELECTROSURGICAL UNIT (August 21, 1995)
  • K946104 — SMOKIEVAC ELECTROSURGICAL PENCIL (April 3, 1995)
  • K944012 — ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (December 21, 1994)
  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

Other clearances for product code FQM

  • K040936 — PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (May 3, 2004)
  • K040054 — BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND A (April 27, 2004)
  • K013244 — COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCA (December 7, 2001)
  • K952738 — SKIN SAVER SYSTEMS (September 29, 1995)
  • K840107 — TUBE-BANDAGE FOR HUMAN DIGITS 200 (April 25, 1984)
  • K831728 — MEDICALEX (January 9, 1984)
  • K830622 — ORTHO WRAP (June 20, 1983)
  • K831551 — COMPRESSOGRIP TUBULAR ELASTIC BANDAGE (June 7, 1983)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)

FDA data resources