510(k) K885274

ROCKET ENDOCERVICAL BRUSH by A & A Medical, Inc. — Product Code HHT

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