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510(k) K911843

ZERO-G(TM) GEL/FOAM MATTRESS TOPPER by Steridyne Corp. — Product Code KIC

K911843 is an FDA 510(k) premarket notification submitted by Steridyne Corp. for the device "ZERO-G(TM) GEL/FOAM MATTRESS TOPPER". The FDA issued a decision of Substantially Equivalent on May 30, 1991. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Steridyne Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1991
Date Received
April 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Flotation
Device Class
Class I
Regulation Number
890.3175
Review Panel
PM
Submission Type

Other clearances by Steridyne Corp.

  • K925352 — CLEAN CUFF BLOOD PRESSURE CUFF LINER (January 12, 1993)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)
  • K842120 — ZERO-G (June 8, 1984)
  • K821314 — FEVER METER (May 28, 1982)
  • K801458 — WINTER HEAD DRESSING (July 28, 1980)

Other clearances for product code KIC

  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K953352 — PROTEAM CUSHION (November 29, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K950085 — MULTICURE(R) S GEL PAD (July 13, 1995)
  • K945667 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (February 21, 1995)
  • K941858 — GEL CUSHION (May 5, 1994)
  • K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (July 30, 1987)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)
  • K864108 — PUSH CUSH (November 14, 1986)
  • K861327 — ROHO HEEL PAD (June 2, 1986)

FDA data resources