Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Wrap, Sterilization

Weihai Xingtai Packaging Products Co.,Ltd.

The following data is part of a premarket notification filed by Weihai Xingtai Packaging Products Co.,ltd. with the FDA for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch.

Pre-market Notification Details

• Device ID: K193561
• 510k Number: K193561
• Device Name: Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
• Classification: Wrap, Sterilization
• Applicant: Weihai Xingtai Packaging Products Co.,Ltd. Sunjiatan Industrial Zone, Yangting Town, Huancui Area Weihai, CN 264200
• Contact: Miao Qifen
• Correspondent: Ray Wang; Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui. No.5, YiHe North Rd., FangShan District Beijing, CN 102401
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-23
• Decision Date: 2020-04-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06977153530095	K193561	000
06977153531122	K193561	000
06977153531139	K193561	000
06977153532068	K193561	000
06977153532075	K193561	000
06977153532082	K193561	000
06977153532099	K193561	000
06977153532105	K193561	000
06977153532129	K193561	000
06977153532136	K193561	000
06977153531115	K193561	000
06977153531108	K193561	000
06977153530088	K193561	000
06977153531023	K193561	000
06977153531030	K193561	000
06977153531047	K193561	000
06977153531054	K193561	000
06977153531061	K193561	000
06977153531078	K193561	000
06977153531085	K193561	000
06977153531092	K193561	000
06977153532143	K193561	000
06977153532150	K193561	000
06977153532167	K193561	000
06977153530026	K193561	000
06977153531016	K193561	000
06977153532013	K193561	000
06977153532020	K193561	000
06977153532051	K193561	000
06977153532112	K193561	000
00840169153793	K193561	000
00860009046467	K193561	000
00860009046474	K193561	000
06977153530019	K193561	000
06977153530002	K193561	000
06977153532174	K193561	000
06977153532198	K193561	000
06977153532204	K193561	000
06977153530033	K193561	000
06977153530071	K193561	000
06977153532037	K193561	000
06977153532044	K193561	000
06977153532181	K193561	000
06977153530040	K193561	000
00860009046481	K193561	000