InstruSafe(R) Sterilization Container

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Summit Medical Inc.

The following data is part of a premarket notification filed by Summit Medical Inc. with the FDA for Instrusafe(r) Sterilization Container.

Pre-market Notification Details

• Device ID: K180528
• 510k Number: K180528
• Device Name: InstruSafe(R) Sterilization Container
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121
• Contact: Nicole Dove
• Correspondent: Nicole Dove; Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-28
• Decision Date: 2018-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00385640084031	K180528	000
00385640082549	K180528	000
00385640082556	K180528	000
00385640082563	K180528	000
00385640082570	K180528	000
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00385640082594	K180528	000
00385640082600	K180528	000
00385640082617	K180528	000
00385640082624	K180528	000
00385640082631	K180528	000
00385640082648	K180528	000
00385640082655	K180528	000
00385640041805	K180528	000
00385640041812	K180528	000
00385640082747	K180528	000
00385640082730	K180528	000
00385640082723	K180528	000
00385640084048	K180528	000
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00385640084109	K180528	000
00385640084147	K180528	000
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00385640084208	K180528	000
00385640084215	K180528	000
00385640084222	K180528	000
00385640082662	K180528	000
00385640082679	K180528	000
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00385640082693	K180528	000
00385640082709	K180528	000
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00385640035170	K180528	000
00385640035378	K180528	000
00385640041829	K180528	000
00385640035248	K180528	000
00385640035255	K180528	000
00385640035262	K180528	000
00385640035279	K180528	000
00385640035286	K180528	000
00385640035293	K180528	000
00385640035309	K180528	000
00385640035316	K180528	000
00385640035323	K180528	000
00385640035330	K180528	000
00385640035347	K180528	000
00385640035354	K180528	000
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00385640039659	K180528	000
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00385640041836	K180528	000
00385640069601	K180528	000
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00385640069670	K180528	000
00385640067041	K180528	000
00385640039871	K180528	000
00385640035187	K180528	000
00385640035194	K180528	000
00385640035200	K180528	000
M6334289000	K180528	000