SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA

Cleanser, Root Canal

INTER-MED, INC.

The following data is part of a premarket notification filed by Inter-med, Inc. with the FDA for Sodium Hypochlorite 3 & 6% Solution And 6% With Wetting Agents To Lower Surface Tension Marketed As Chlor-xtra.

Pre-market Notification Details

Device IDK082470
510k NumberK082470
Device Name:SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
ClassificationCleanser, Root Canal
Applicant INTER-MED, INC. 2200 NORTHWESTERN AVE. Racine,  WI  53404
ContactGeorge Horvat
CorrespondentGeorge Horvat
INTER-MED, INC. 2200 NORTHWESTERN AVE. Racine,  WI  53404
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-27
Decision Date2009-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889813028070 K082470 000
10818207020618 K082470 000
10818207020397 K082470 000
10818207020403 K082470 000
10818207020410 K082470 000
10818207020427 K082470 000
10818207020434 K082470 000
10818207020441 K082470 000
10818207020458 K082470 000
10818207020465 K082470 000
10818207020472 K082470 000
10818207020489 K082470 000
10818207020496 K082470 000
10818207020502 K082470 000
H658711265161 K082470 000
10818207020601 K082470 000

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