BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,

Catheter, Urethral

HANGZHOU BEVER MEDICAL DEVICES CO., LTD.

The following data is part of a premarket notification filed by Hangzhou Bever Medical Devices Co., Ltd. with the FDA for Bever Unocated / Coated, Paediatric / Male / Female Nelaton-tip / Tiemann-tip Intermittent Catheter,.

Pre-market Notification Details

• Device ID: K111405
• 510k Number: K111405
• Device Name: BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
• Classification: Catheter, Urethral
• Applicant: HANGZHOU BEVER MEDICAL DEVICES CO., LTD. NO. 8-1, LONGQUAN ROAD CANGQIAN TOWN, YUHANG DISTRICT Hangzhou, Zhejiang, CN 311121
• Contact: Allyson Zhou
• Correspondent: Allyson Zhou; HANGZHOU BEVER MEDICAL DEVICES CO., LTD. NO. 8-1, LONGQUAN ROAD CANGQIAN TOWN, YUHANG DISTRICT Hangzhou, Zhejiang, CN 311121
• Product Code: GBM
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-19
• Decision Date: 2012-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40612479242331	K111405	000
16948796203865	K111405	000
16948796203858	K111405	000
16948796203841	K111405	000
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10817668010572	K111405	000
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10817668010558	K111405	000
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10817668010527	K111405	000
10817668010510	K111405	000
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16948796203889	K111405	000
40612479242300	K111405	000
40612479242270	K111405	000
40612479242249	K111405	000
40612479242218	K111405	000
16948796203896	K111405	000
16948796203940	K111405	000
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16948796203926	K111405	000
16948796203919	K111405	000
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10817668010503	K111405	000
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10817668010107	K111405	000
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10817668010022	K111405	000
10850025153284	K111405	000
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40612479242782	K111405	000
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40612479242362	K111405	000