Cleared Traditional

MICROSCOPE KNOB COVER, STERILE, DISPOSABLE

K891001 · Prescott'S, Inc. · General & Plastic Surgery

Apr 1989

Decision

43d

Days

Class 1

Risk

About This 510(k) Submission

K891001 is an FDA 510(k) clearance for the MICROSCOPE KNOB COVER, STERILE, DISPOSABLE, a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I — General Controls, product code HRM), submitted by Prescott'S, Inc. (Monument, US). The FDA issued a Cleared decision on April 11, 1989, 43 days after receiving the submission on February 27, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number	K891001 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1989
Decision Date	April 11, 1989
Days to Decision	43 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—