Cleared Traditional

ROCKET CERVICAL SPATULA

K884042 · A & A Medical, Inc. · Obstetrics & Gynecology
Oct 1988
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K884042 is an FDA 510(k) clearance for the ROCKET CERVICAL SPATULA, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on October 7, 1988, 11 days after receiving the submission on September 26, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K884042 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1988
Decision Date October 07, 1988
Days to Decision 11 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHT — Spatula, Cervical, Cytological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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