CATARHEX 3

Unit, Phacofragmentation

OERTLI INSTRUMENTE AG

The following data is part of a premarket notification filed by Oertli Instrumente Ag with the FDA for Catarhex 3.

Pre-market Notification Details

• Device ID: K133562
• 510k Number: K133562
• Device Name: CATARHEX 3
• Classification: Unit, Phacofragmentation
• Applicant: OERTLI INSTRUMENTE AG HAFNERWISENSTRASSE 4 Berneck, CH 9442
• Contact: Karin Rohr
• Correspondent: Karin Rohr; OERTLI INSTRUMENTE AG HAFNERWISENSTRASSE 4 Berneck, CH 9442
• Product Code: HQC
• Subsequent Product Code: GEI
• Subsequent Product Code: HQE
• CFR Regulation Number: 886.4670 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-20
• Decision Date: 2014-08-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630003913781	K133562	000
07630003901337	K133562	000
07630003901351	K133562	000
07630003901368	K133562	000
07630003901382	K133562	000
07630003901597	K133562	000
07630003901832	K133562	000
07630003902211	K133562	000
07630003903829	K133562	000
07630003903867	K133562	000
07630003903874	K133562	000
07630003904239	K133562	000
07630003904284	K133562	000
07630003904390	K133562	000
07630003901177	K133562	000
07630003901160	K133562	000
07630003901146	K133562	000
07630003913804	K133562	000
07630003913798	K133562	000
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07630003900415	K133562	000
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07630003900514	K133562	000
07630003900941	K133562	000
07630003900958	K133562	000
07630003901023	K133562	000
07630003901030	K133562	000
07630003901054	K133562	000
07630003901115	K133562	000
07630003904789	K133562	000
07630003905526	K133562	000
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07630003910315	K133562	000
07630003910445	K133562	000
07630003910452	K133562	000
07630003910704	K133562	000
07630003910735	K133562	000
07630003910759	K133562	000
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07630003910001	K133562	000
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07630003909852	K133562	000
07630003909906	K133562	000
07630003913064	K133562	000