510(k) K895551

ROCKET BONE MARROW NEEDLE by A & A Medical, Inc. — Product Code GDM

K895551 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "ROCKET BONE MARROW NEEDLE". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
September 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type