510(k) K823594

PLASTIC BUILT-UP HANDLE EATING UTENSILS by Fred Sammons, Inc. — Product Code ILC

K823594 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "PLASTIC BUILT-UP HANDLE EATING UTENSILS". The FDA issued a decision of Substantially Equivalent on December 22, 1982. The device falls under product code ILC (Utensil, Eating), a Class I device regulated under 21 CFR 890.5050. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1982
Date Received
December 6, 1982
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