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510(k) K950085

MULTICURE(R) S GEL PAD by Multigestion (Deutschland) GmbH — Product Code KIC

K950085 is an FDA 510(k) premarket notification submitted by Multigestion (Deutschland) GmbH for the device "MULTICURE(R) S GEL PAD". The FDA issued a decision of Substantially Equivalent on July 13, 1995. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1995
Date Received
January 10, 1995
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 for product code KIC

  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K953352 — PROTEAM CUSHION (November 29, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K945667 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (February 21, 1995)
  • K941858 — GEL CUSHION (May 5, 1994)
  • K911843 — ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (May 30, 1991)
  • 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