EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER

Lavage, Jet

ALCAVIS INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Alcavis International, Inc. with the FDA for Exsept Wc Antimicrobial Skin And Wound Cleanser.

Pre-market Notification Details

• Device ID: K082858
• 510k Number: K082858
• Device Name: EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
• Classification: Lavage, Jet
• Applicant: ALCAVIS INTERNATIONAL, INC. 8322 HELGERMAN COURT Gaithersburg, MD 20877
• Contact: Gary J Mishkin
• Correspondent: Gary J Mishkin; ALCAVIS INTERNATIONAL, INC. 8322 HELGERMAN COURT Gaithersburg, MD 20877
• Product Code: FQH
• CFR Regulation Number: 880.5475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2008-09-29
• Decision Date: 2009-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20898021000109	K082858	000
00898021000099	K082858	000
00898021000082	K082858	000
20898021000079	K082858	000
00898021000372	K082858	000