THE ULTRA SYSTEM

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

PROMEDICA, INC.

The following data is part of a premarket notification filed by Promedica, Inc. with the FDA for The Ultra System.

Pre-market Notification Details

• Device ID: K032445
• 510k Number: K032445
• Device Name: THE ULTRA SYSTEM
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: PROMEDICA, INC. 114 DOUGLAS RD EAST Oldsmar, FL 34677
• Contact: Richard Bloom
• Correspondent: Richard Bloom; PROMEDICA, INC. 114 DOUGLAS RD EAST Oldsmar, FL 34677
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-08
• Decision Date: 2004-03-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00887482143896	K032445	000
00887482137727	K032445	000
00887482137710	K032445	000
00887482137703	K032445	000
00887482137680	K032445	000
00887482137673	K032445	000
00887482137659	K032445	000
00887482137635	K032445	000
00887482137628	K032445	000
00887482137604	K032445	000
00887482137598	K032445	000
00887482137574	K032445	000
00887482137741	K032445	000
00887482137765	K032445	000
00887482137789	K032445	000
00887482138175	K032445	000
00887482137918	K032445	000
00887482137901	K032445	000
00887482137895	K032445	000
00887482137888	K032445	000
00887482137871	K032445	000
00887482137857	K032445	000
00887482137840	K032445	000
00887482137826	K032445	000
00887482137819	K032445	000
00887482137796	K032445	000
00887482137550	K032445	000