THE INSYNC CERAMIC SYSTEM

Powder, Porcelain

JENSEN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for The Insync Ceramic System.

Pre-market Notification Details

• Device ID: K111743
• 510k Number: K111743
• Device Name: THE INSYNC CERAMIC SYSTEM
• Classification: Powder, Porcelain
• Applicant: JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Contact: Gary Phelps
• Correspondent: Gary Phelps; JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-21
• Decision Date: 2011-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817340025460	K111743	000
00817340025675	K111743	000
00817340025668	K111743	000
00817340025651	K111743	000
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00817340025835	K111743	000
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00817340025996	K111743	000
00817340025477	K111743	000
00817340023367	K111743	000
00817340025514	K111743	000
00817340025507	K111743	000
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00817340025132	K111743	000