510(k) K902589
K902589 is an FDA 510(k) premarket notification submitted by Birchwood Laboratories, Inc. for the device "CYTOSET(TM)". The FDA issued a decision of Substantially Equivalent on Sep 10, 1990. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Birchwood Laboratories, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 10, 1990
- Date Received
- Jun 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spatula, Cervical, Cytological
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k)