Cleared Traditional

MMODIFICATION TO LAMINARIA

K011512 · A & A Medical, Inc. · Obstetrics & Gynecology
Jul 2001
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K011512 is an FDA 510(k) clearance for the MMODIFICATION TO LAMINARIA, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 9, 2001, 54 days after receiving the submission on May 16, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.

Submission Details

510(k) Number K011512 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2001
Decision Date July 09, 2001
Days to Decision 54 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HDY — Dilator, Cervical, Hygroscopic-laminaria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4260