510(k) K885274
K885274 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ROCKET ENDOCERVICAL BRUSH". The FDA issued a decision of Substantially Equivalent on March 9, 1989. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1989
- Date Received
- December 22, 1988
- 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