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510(k) K820094

ELASTIC BANDAGE by Stan-Pak Ent. — Product Code FQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
January 13, 1982
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 Stan-Pak Ent.

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  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K820099 — TRACH TAPE (February 23, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)

Other clearances for product code FQM

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  • 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)
  • K872868 — ASPEN ESMARK BANDAGE (July 31, 1987)
  • 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)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)