ERMIS STERILIZATION CONTAINER SYSTEM

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

ERMIS MEDIZINTECHNIK

The following data is part of a premarket notification filed by Ermis Medizintechnik with the FDA for Ermis Sterilization Container System.

Pre-market Notification Details

• Device ID: K123234
• 510k Number: K123234
• Device Name: ERMIS STERILIZATION CONTAINER SYSTEM
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: ERMIS MEDIZINTECHNIK GRIESWEG 47 Muehlheim, Baden-wuerttemberg, DE 78570
• Contact: Andre Weingerl
• Correspondent: Andre Weingerl; ERMIS MEDIZINTECHNIK GRIESWEG 47 Muehlheim, Baden-wuerttemberg, DE 78570
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-10-15
• Decision Date: 2013-07-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049047667827	K123234	000
00840314248152	K123234	000
00840314248169	K123234	000
00840314248176	K123234	000
00840314248183	K123234	000
00840314248190	K123234	000
00840314248206	K123234	000
00840314248213	K123234	000
00840314248220	K123234	000
00840314248237	K123234	000
00840314248244	K123234	000
00840314248145	K123234	000
00840314248138	K123234	000
04049047673002	K123234	000
00840314247902	K123234	000
00840314247919	K123234	000
00840314247926	K123234	000
00840314247933	K123234	000
00840314247940	K123234	000
00840314247957	K123234	000
00840314247964	K123234	000
00840314248114	K123234	000
00840314248121	K123234	000
00840314248251	K123234	000
00840314248268	K123234	000
00840314248398	K123234	000
00840314248404	K123234	000
00840314248411	K123234	000
00840314248428	K123234	000
00840314248435	K123234	000
10889950035433	K123234	000
10889950035440	K123234	000
10889950035471	K123234	000
10889950035488	K123234	000
10889950035495	K123234	000
00840314248381	K123234	000
00840314248374	K123234	000
00840314248275	K123234	000
00840314248282	K123234	000
00840314248299	K123234	000
00840314248305	K123234	000
00840314248312	K123234	000
00840314248329	K123234	000
00840314248336	K123234	000
00840314248343	K123234	000
00840314248350	K123234	000
00840314248367	K123234	000
10889950038472	K123234	000