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510(k) K821858

NOTIE STRETCH-LACE-VARIOUS MODELS by Fred Sammons, Inc. — Product Code ILD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Dressing
Device Class
Class I
Regulation Number
890.5050
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)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)

Other clearances for product code ILD

  • K831539 — ECONOMY PLASTIC SOCK-BK2084-AID (June 8, 1983)
  • K823628 — LEATHER & VELCRO SHOE FASTENER (December 28, 1982)
  • K823603 — FORMED PLASTIC PANTY HOSE AID (December 28, 1982)
  • K823627 — LEATHER I VELCRO SHOE FASTENER REPAIR (December 28, 1982)
  • K823604 — ROD W/HOOK TO PULL CLOTHES ON (December 28, 1982)
  • K823602 — REGULAR SHOE HORN W/CYLINDRICAL HANDLE (December 22, 1982)
  • K821859 — ORTHOLACE 4,5.6 EYELET (July 2, 1982)
  • K821856 — BK-2082 FOLDING STOCKING AID (July 2, 1982)
  • K813634 — ONE HANDED SHOE FASTENER (January 19, 1982)
  • K811492 — DRESSING ADAPTORS (June 12, 1981)