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510(k) K833177

GLOSSECTOMY FEEDING SPOONS by Maddak, Inc. — Product Code ILC

K833177 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "GLOSSECTOMY FEEDING SPOONS". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code ILC (Utensil, Eating), a Class I device regulated under 21 CFR 890.5050. Maddak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
September 19, 1983
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

Other clearances by Maddak, Inc.

  • K841700 — WALK & ROLL (May 11, 1984)
  • K841695 — CRAWLER (May 10, 1984)
  • K841698 — HEAT PACK (May 10, 1984)
  • K841697 — HYDRO-THERO PAD (May 9, 1984)
  • K841691 — SPLIT SEAT POSITIONING CHAIR (May 9, 1984)
  • K841693 — STANDING FRAME (May 9, 1984)
  • K841692 — PRONE STANDER (May 9, 1984)
  • K834311 — NIGHT TRAINER (March 30, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833090 — SENSORY ROLLER MASSAGER (October 14, 1983)

Other clearances for product code ILC

  • K830854 — COLLAPSABLE LAVATORY SEAT HEIGHTENER (April 5, 1983)
  • K830851 — BATH TUB SEAT & BATH BOARD (April 5, 1983)
  • K823594 — PLASTIC BUILT-UP HANDLE EATING UTENSILS (December 22, 1982)
  • K821643 — EATING UTENSILS (June 11, 1982)
  • K813630 — BK-1129 BOTTLE STRAW (January 19, 1982)
  • K812346 — ALUMINUM SCOOP DISK (September 11, 1981)
  • K811488 — FEEDING AID KIT (June 12, 1981)
  • K810455 — EATING UTENSILS (March 4, 1981)
  • K801705 — BK-1424 INNER LIP PLATE, CERAMIC (August 7, 1980)
  • K801706 — BK-1426-00-01 STONYBROOK/HI-WALL PLATE (August 7, 1980)

FDA data resources