DENTAL WARM WATER IRRIGATING SYSTEM

Unit, Syringe, Air And/or Water

RAMA CORP.

The following data is part of a premarket notification filed by Rama Corp. with the FDA for Dental Warm Water Irrigating System.

Pre-market Notification Details

Device IDK781594
510k NumberK781594
Device Name:DENTAL WARM WATER IRRIGATING SYSTEM
ClassificationUnit, Syringe, Air And/or Water
Applicant RAMA CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeECB  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-15
Decision Date1978-12-04

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