AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP

Tissue Adhesive For The Topical Approximation Of Skin

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Histoacryl, Histoacryl Blue And Histoacryl Flexible Topical Skin, Adhesive With Applicator Tip.

Pre-market Notification Details

• Device ID: K140343
• 510k Number: K140343
• Device Name: AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP
• Classification: Tissue Adhesive For The Topical Approximation Of Skin
• Applicant: AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034
• Contact: Kathy A Racosky
• Correspondent: Kathy A Racosky; AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034
• Product Code: MPN
• CFR Regulation Number: 878.4010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-11
• Decision Date: 2014-05-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10860000589038	K140343	000
30009336010043	K140343	000