510(k) K802577

HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY by Associated Medical Products Co. — Product Code FRG

K802577 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type