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510(k) K801458

WINTER HEAD DRESSING by Steridyne Corp. — Product Code FQM

K801458 is an FDA 510(k) premarket notification submitted by Steridyne Corp. for the device "WINTER HEAD DRESSING". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. Steridyne Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 24, 1980
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 Steridyne Corp.

  • K925352 — CLEAN CUFF BLOOD PRESSURE CUFF LINER (January 12, 1993)
  • K911843 — ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (May 30, 1991)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)
  • K842120 — ZERO-G (June 8, 1984)
  • K821314 — FEVER METER (May 28, 1982)

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)
  • 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)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)

FDA data resources