Cleared Traditional

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5

K980783 · Irt Management Corp. · Dental

Apr 1998

Decision

50d

Days

Class 1

Risk

About This 510(k) Submission

K980783 is an FDA 510(k) clearance for the SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5, a Absorber, Saliva, Paper (Class I — General Controls, product code KHR), submitted by Irt Management Corp. (Hallandale, US). The FDA issued a Cleared decision on April 21, 1998, 50 days after receiving the submission on March 2, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.6050.

Submission Details

510(k) Number	K980783 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1998
Decision Date	April 21, 1998
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement