510(k) K881456

PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE by Laboratoire Ccd C/O Washington Regulatory Services — Product Code HHK

K881456 is an FDA 510(k) premarket notification submitted by Laboratoire Ccd C/O Washington Regulatory Services for the device "PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE". The FDA issued a decision of Substantially Equivalent on October 14, 1988. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Laboratoire Ccd C/O Washington Regulatory Services has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1988
Date Received
April 6, 1988
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