510(k) K823006

MEDEVICES ASPIRATION HOSE by Berkeley Medevices — Product Code HHK

K823006 is an FDA 510(k) premarket notification submitted by Berkeley Medevices for the device "MEDEVICES ASPIRATION HOSE". The FDA issued a decision of Substantially Equivalent on November 4, 1982. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Berkeley Medevices has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1982
Date Received
October 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type