Cleared Traditional

K842953 - ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
(FDA 510(k) Clearance)

K842953 · All-Hands Medical Supply, Inc. · Orthopedic device

Aug 1984

Decision

25d

Days

Class 1

Risk

K842953 is an FDA 510(k) clearance for the ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL. This device is classified as a Scissors, Orthopedic, Surgical (Class I - General Controls, product code HRR).

Submitted by All-Hands Medical Supply, Inc. (Walker, US). The FDA issued a Cleared decision on August 21, 1984, 25 days after receiving the submission on July 27, 1984.

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

Submission Details

510(k) Number	K842953 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1984
Decision Date	August 21, 1984
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—