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510(k) K831540

COMPRESSOGRIP ELASTIC STUMP SHRINKER# by Fred Sammons, Inc. — Product Code ILG

K831540 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "COMPRESSOGRIP ELASTIC STUMP SHRINKER#". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
May 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Elastic
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)

Other clearances for product code ILG

  • K833437 — ORTHOPEDIC STOCKINETTE (November 3, 1983)
  • K780612 — STOCKINETTE, STERILE (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)
  • K760817 — ORTHOPEDIC TUBULAR STOCKINETTE (October 20, 1976)
  • K760576 — TOURNIWRAP BANDAGE (October 5, 1976)

FDA data resources