Cleared Traditional

K870083 - FERRAY EXTRACTOR (FDA 510(k) Clearance)

K870083 · Terray Manufacturing, Inc. · Orthopedic device

Feb 1987

Decision

49d

Days

Class 1

Risk

K870083 is an FDA 510(k) clearance for the FERRAY EXTRACTOR. This device is classified as a Extractor (Class I - General Controls, product code HWB).

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on February 26, 1987, 49 days after receiving the submission on January 8, 1987.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K870083 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 1987
Decision Date	February 26, 1987
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—