VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM

Material, Impression

CROWN DELTA CORP.

The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Vinyl Polysiloxane 2 Component Vulcanizing System.

Pre-market Notification Details

Device IDK930248
510k NumberK930248
Device Name:VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM
ClassificationMaterial, Impression
Applicant CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights,  NY  10598
ContactLaurence Colin
CorrespondentLaurence Colin
CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights,  NY  10598
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-19
Decision Date1994-01-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816519021272 K930248 000
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D773290000041 K930248 000
D773290000031 K930248 000
D773290000021 K930248 000
00816526021708 K930248 000

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