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510(k) K801706

BK-1426-00-01 STONYBROOK/HI-WALL PLATE by Fred Sammons, Inc. — Product Code ILC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Utensil, Eating
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

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  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
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  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
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  • K821643 — EATING UTENSILS (June 11, 1982)
  • K813630 — BK-1129 BOTTLE STRAW (January 19, 1982)
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  • K811488 — FEEDING AID KIT (June 12, 1981)
  • K810455 — EATING UTENSILS (March 4, 1981)
  • K801705 — BK-1424 INNER LIP PLATE, CERAMIC (August 7, 1980)