SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

Dressing, Wound, Drug

WINCHESTER LABORATORIES LLC.

The following data is part of a premarket notification filed by Winchester Laboratories Llc. with the FDA for Saljet Single Dose Sterile Saline Topical Solution.

Pre-market Notification Details

Device IDK993969
510k NumberK993969
Device Name:SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
ClassificationDressing, Wound, Drug
Applicant WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia,  IL  60510
ContactHoward Rose
CorrespondentHoward Rose
WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia,  IL  60510
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-23
Decision Date1999-12-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40612479271294 K993969 000
60188151000000 K993969 000

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