510(k) K854415
K854415 is an FDA 510(k) premarket notification submitted by Unimar, Inc. for the device "ENDOMETRIAL PIPELLE". The FDA issued a decision of Substantially Equivalent on March 13, 1986. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Unimar, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1986
- Date Received
- November 4, 1985
- 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