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510(k) K831706

SATO FAMILY FIRST AID KIT by Food and Drug Service, Inc. — Product Code ILI

K831706 is an FDA 510(k) premarket notification submitted by Food and Drug Service, Inc. for the device "SATO FAMILY FIRST AID KIT". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Food and Drug Service, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
May 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm
Device Class
Class I
Regulation Number
890.3640
Review Panel
PM
Submission Type

Other clearances by Food and Drug Service, Inc.

  • K823076 — SATOBAN FIRST AID TAPE (January 12, 1983)

Other clearances for product code ILI

  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K823808 — VARIOUS ARM SLING (January 14, 1983)
  • K823810 — A.C. SPLINT (January 14, 1983)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823162 — UNIVERSAL SLING, SLING & SWATHE (November 10, 1982)
  • K820590 — ORTHOPEDIC SOFT GOODS (March 26, 1982)
  • K812477 — ARM SLING, POUCH TYPE (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)
  • K812480 — LIMB HOLDER ARM SLING (September 14, 1981)

FDA data resources