510(k) K881220

ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER by Laboratoire Ccd C/O Washington Regulatory Services — Product Code HFE

K881220 is an FDA 510(k) premarket notification submitted by Laboratoire Ccd C/O Washington Regulatory Services for the device "ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on June 14, 1988. The device falls under product code HFE (Brush, Endometrial), a Class II device regulated under 21 CFR 884.1100. 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
June 14, 1988
Date Received
March 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Endometrial
Device Class
Class II
Regulation Number
884.1100
Review Panel
OB
Submission Type