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510(k) K915368

SERENA WHEELCHAIR CUSHIONS by A & C Medical Supply — Product Code KNN

K915368 is an FDA 510(k) premarket notification submitted by A & C Medical Supply for the device "SERENA WHEELCHAIR CUSHIONS". The FDA issued a decision of Substantially Equivalent on December 20, 1991. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1991
Date Received
November 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

Other clearances for product code KNN

  • K211919 — KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat (March 4, 2022)
  • K942310 — DYNASTY GC 12550 (GELL/CELL) (November 7, 1994)
  • K942311 — DYNASTY U1-33 AGM (November 7, 1994)
  • K942308 — DYNASTY GC 12400 (GELL/CELL) (November 7, 1994)
  • K942309 — DYNASTY U1-31 (GELL/CELL) (November 7, 1994)
  • K942312 — ALDEN LINEAGE WHEELCHAIR CUSHION (May 26, 1994)
  • K942260 — ALDEN WHEELCHAIR CUSHION (May 26, 1994)
  • K933051 — ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION (October 12, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K925980 — PM (March 24, 1993)

FDA data resources