Apis

Dressing, Wound, Drug

SweetBio, Inc

The following data is part of a premarket notification filed by Sweetbio, Inc with the FDA for Apis.

Pre-market Notification Details

• Device ID: K182725
• 510k Number: K182725
• Device Name: Apis
• Classification: Dressing, Wound, Drug
• Applicant: SweetBio, Inc 20 Dudley Street, Suite 900 Memphis, TN 38103 -4904
• Contact: Kayla Graff
• Correspondent: Carolyn Guthrie; Kapstone Medical, LLC PO Box 969 Leicester, NC 28748
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-28
• Decision Date: 2019-05-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861876000354	K182725	000
00861876000316	K182725	000
00861876000309	K182725	000
00861876000378	K182725	000
00861876000361	K182725	000