510(k) K881220
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