510(k) K870398
K870398 is an FDA 510(k) premarket notification submitted by Medical Packaging Corp. for the device "PAP-PAK CYTOBRUSH KIT". The FDA issued a decision of Substantially Equivalent on February 25, 1987. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Medical Packaging Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1987
- Date Received
- February 2, 1987
- 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