U&U Sterilization Pouch And Roll

Wrap, Sterilization

U&U Medical Technology Co.,Ltd

The following data is part of a premarket notification filed by U&u Medical Technology Co.,ltd with the FDA for U&u Sterilization Pouch And Roll.

Pre-market Notification Details

• Device ID: K143637
• 510k Number: K143637
• Device Name: U&U Sterilization Pouch And Roll
• Classification: Wrap, Sterilization
• Applicant: U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu, CN 213119
• Contact: Garfield Wang
• Correspondent: Garfield Wang; U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu, CN 213119
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-22
• Decision Date: 2015-09-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810132802133	K143637	000
10843471153052	K143637	000
10843471153069	K143637	000
20843471153073	K143637	000
10843471153083	K143637	000
D773600100032	K143637	000
D773600100042	K143637	000
D773600100052	K143637	000
D773600100062	K143637	000
D773600100071	K143637	000
D773600100081	K143637	000
D773600100091	K143637	000
90816577021361	K143637	000
90816577021385	K143637	000
20843471153042	K143637	000
20843471153035	K143637	000
10843471128913	K143637	000
10843471131692	K143637	000
10843471131708	K143637	000
10843471131715	K143637	000
10843471131722	K143637	000
10843471147723	K143637	000
10843471147730	K143637	000
10843471147747	K143637	000
10843471152987	K143637	000
10843471152994	K143637	000
10843471153007	K143637	000
10843471153014	K143637	000
20843471153028	K143637	000
90816577021408	K143637	000
90816577021422	K143637	000
90817800020205	K143637	000
90817800020229	K143637	000
90817800020243	K143637	000
00816577022518	K143637	000
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00816577022549	K143637	000
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00816577022563	K143637	000
00816577022570	K143637	000
00816577022587	K143637	000
00816577022594	K143637	000
00816577022600	K143637	000
90817800020182	K143637	000
90817800020168	K143637	000
90816577021446	K143637	000
90816577021460	K143637	000
90816577021484	K143637	000
90816577021507	K143637	000
90816577021521	K143637	000
90816577021545	K143637	000
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90817800020045	K143637	000
90817800020069	K143637	000
90817800020083	K143637	000
90817800020106	K143637	000
90817800020120	K143637	000
90817800020144	K143637	000
00816577022617	K143637	000