510(k) K902693
K902693 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "WALLACH FLEXIBLE ENDOMETRIAL SAMPLER". The FDA issued a decision of Substantially Equivalent on Jan 31, 1991. The device falls under product code HFF (Aspirator, Endometrial), a Class II device regulated under 21 CFR 884.1060. Wallach Surgical Devices, Inc. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 31, 1991
- Date Received
- Jun 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Aspirator, Endometrial
- Device Class
- Class II
- Regulation Number
- 884.1060
- Review Panel
- OB
- Submission Type
- 510(k)