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510(k) K821260

VITOFIT by Selomas, Inc. — Product Code FQL

K821260 is an FDA 510(k) premarket notification submitted by Selomas, Inc. for the device "VITOFIT". The FDA issued a decision of Substantially Equivalent on June 23, 1982. The device falls under product code FQL (Stocking, Medical Support (For General Medical Purposes)), a Class I device regulated under 21 CFR 880.5780. Selomas, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1982
Date Received
April 30, 1982
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 Selomas, Inc.

  • K861215 — GAUZE SPONGES USP TYPE VII (April 17, 1986)
  • K821258 — SELOPOR (August 19, 1982)
  • K821259 — VITASAN (June 23, 1982)
  • K821490 — SILKAFIX ADHESIVE PLASTER (June 2, 1982)
  • K821257 — SELOFIX (May 14, 1982)
  • K812501 — OPRAFLEX (October 2, 1981)

Other clearances for product code FQL

  • K944240 — SOFT SOCK (December 27, 1994)
  • K823789 — ELASTIC COMPRESSION ANKLET (January 7, 1983)
  • K823350 — ELASTIC COMPRESSION ANKLET (December 3, 1982)
  • K821259 — VITASAN (June 23, 1982)
  • K820484 — VENES CUSTON RX (March 18, 1982)

FDA data resources