Cleared Traditional

K883806 - ROCKET INTRAUTERINE SOUND
(FDA 510(k) Clearance)

K883806 · A & A Medical, Inc. · Obstetrics & Gynecology device

Oct 1988

Decision

54d

Days

Class 1

Risk

K883806 is an FDA 510(k) clearance for the ROCKET INTRAUTERINE SOUND. This device is classified as a Sound, Uterine (Class I - General Controls, product code HHM).

Submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on October 31, 1988, 54 days after receiving the submission on September 7, 1988.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K883806 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 07, 1988
Decision Date	October 31, 1988
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—