Cleared Traditional

K925395 - TECHNOMED PULSOLITH 4000 LASER SYSTEM
(FDA 510(k) Clearance)

K925395 · Teknomed, Inc. · General Hospital

May 1993

Decision

207d

Days

Class 2

Risk

K925395 is an FDA 510(k) clearance for the TECHNOMED PULSOLITH 4000 LASER SYSTEM, a Laser For Gastro-urology Use (Class II — Special Controls, product code LNK), submitted by Teknomed, Inc. (Danvers, US). The FDA issued a Cleared decision on May 21, 1993, 207 days after receiving the submission on October 26, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K925395 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 1992
Decision Date	May 21, 1993
Days to Decision	207 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF