510(k) K823627

LEATHER I VELCRO SHOE FASTENER REPAIR by Fred Sammons, Inc. — Product Code ILD

K823627 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "LEATHER I VELCRO SHOE FASTENER REPAIR". The FDA issued a decision of Substantially Equivalent on Dec 28, 1982. The device falls under product code ILD (Adaptor, Dressing), 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
Dec 28, 1982
Date Received
Dec 6, 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