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510(k) K944240

SOFT SOCK by Silipos, Inc. — Product Code FQL

K944240 is an FDA 510(k) premarket notification submitted by Silipos, Inc. for the device "SOFT SOCK". The FDA issued a decision of Substantially Equivalent on December 27, 1994. The device falls under product code FQL (Stocking, Medical Support (For General Medical Purposes)), a Class I device regulated under 21 CFR 880.5780. Silipos, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
September 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (For General Medical Purposes)
Device Class
Class I
Regulation Number
880.5780
Review Panel
HO
Submission Type

Other clearances by Silipos, Inc.

  • K955664 — STERILIZED TRI BLOCK POLYMER GEL SHEET (February 28, 1996)
  • K942695 — TRI BLOCK POLUMER GEL SHEETING (November 10, 1994)
  • K932048 — SILICONE GEL SHEETING (January 7, 1994)

Other clearances for product code FQL

  • K823789 — ELASTIC COMPRESSION ANKLET (January 7, 1983)
  • K823350 — ELASTIC COMPRESSION ANKLET (December 3, 1982)
  • K821260 — VITOFIT (June 23, 1982)
  • K821259 — VITASAN (June 23, 1982)
  • K820484 — VENES CUSTON RX (March 18, 1982)

FDA data resources