Cleared Traditional

ROCKET BONE MARROW NEEDLE

K895551 · A & A Medical, Inc. · General & Plastic Surgery
Oct 1989
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K895551 is an FDA 510(k) clearance for the ROCKET BONE MARROW NEEDLE, a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on October 6, 1989, 23 days after receiving the submission on September 13, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K895551 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1989
Decision Date October 06, 1989
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDM — Needle, Aspiration And Injection, Reusable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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