Cleared Traditional

DELTA-ROL

K790340 · Johnson & Johnson Professionals, Inc. · Gastroenterology & Urology

Apr 1979

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K790340 is an FDA 510(k) clearance for the DELTA-ROL, a Endoscope, Mirror (Class II — Special Controls, product code GCO), submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on April 12, 1979, 50 days after receiving the submission on February 21, 1979. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K790340 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1979
Decision Date	April 12, 1979
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—