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510(k) K771031

STROKE SLING by Stat Medical Corp. — Product Code ILI

K771031 is an FDA 510(k) premarket notification submitted by Stat Medical Corp. for the device "STROKE SLING". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Stat Medical Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1977
Date Received
June 9, 1977
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 Stat Medical Corp.

  • K780171 — ELBOW PROTECTOR (February 6, 1978)
  • K771030 — FLEXION MITTENS (June 27, 1977)
  • K770853 — STERILE COTTON (May 23, 1977)

Other clearances for product code ILI

  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831706 — SATO FAMILY FIRST AID KIT (June 24, 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)
  • K812480 — LIMB HOLDER ARM SLING (September 14, 1981)
  • K812478 — MADDACOMFORT SLING (September 14, 1981)

FDA data resources