Cleared Traditional

PERCUSSION HAMMER

K891571 · Sandal Surgico · Neurology

Mar 1989

Decision

11d

Days

Class 1

Risk

About This 510(k) Submission

K891571 is an FDA 510(k) clearance for the PERCUSSION HAMMER, a Percussor (Class I — General Controls, product code GWZ), submitted by Sandal Surgico (Sialkot, PK). The FDA issued a Cleared decision on March 31, 1989, 11 days after receiving the submission on March 20, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1700.

Submission Details

510(k) Number	K891571 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 1989
Decision Date	March 31, 1989
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—