STERIKING STERILIZATION POUCHES & ROLLS

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

WIHURI OY

The following data is part of a premarket notification filed by Wihuri Oy with the FDA for Steriking Sterilization Pouches & Rolls.

Pre-market Notification Details

• Device ID: K953776
• 510k Number: K953776
• Device Name: STERIKING STERILIZATION POUCHES & ROLLS
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: WIHURI OY COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; WIHURI OY COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-11
• Decision Date: 1995-10-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438263610409	K953776	000
06438263610812	K953776	000
06438263610829	K953776	000
06438263610836	K953776	000
06438263610850	K953776	000
06438263610867	K953776	000
06438263610911	K953776	000
06438263610935	K953776	000
06438263610973	K953776	000
06438263610997	K953776	000
06438263630131	K953776	000
06438263630148	K953776	000
06438263630179	K953776	000
06438263630186	K953776	000
06438263610591	K953776	000
06438263610584	K953776	000
06438263610416	K953776	000
06438263610423	K953776	000
06438263610447	K953776	000
06438263610454	K953776	000
06438263610461	K953776	000
06438263610485	K953776	000
06438263610492	K953776	000
06438263610515	K953776	000
06438263610522	K953776	000
06438263610539	K953776	000
06438263610546	K953776	000
06438263610553	K953776	000
06438263610577	K953776	000
06438263630193	K953776	000
06438263630209	K953776	000
06438263650122	K953776	000
06438263650139	K953776	000
06438263650146	K953776	000
06438263650153	K953776	000
06438263650160	K953776	000
06438263661975	K953776	000
06438263661999	K953776	000
06438263662002	K953776	000
06438263662019	K953776	000
06438263662026	K953776	000
06438263662033	K953776	000
06438263662040	K953776	000
06438263660527	K953776	000
06438263650115	K953776	000
06438263650108	K953776	000
06438263640277	K953776	000
06438263640284	K953776	000
06438263640291	K953776	000
06438263640314	K953776	000
06438263640338	K953776	000
06438263640345	K953776	000
06438263640802	K953776	000
06438263640819	K953776	000
06438263640826	K953776	000
06438263640833	K953776	000
06438263640840	K953776	000
06438263640857	K953776	000
06438263640864	K953776	000
06438263662064	K953776	000