SENSUA!

Condom

AAC CONSULTING GROUP, INC.

The following data is part of a premarket notification filed by Aac Consulting Group, Inc. with the FDA for Sensua!.

Pre-market Notification Details

• Device ID: K021125
• 510k Number: K021125
• Device Name: SENSUA!
• Classification: Condom
• Applicant: AAC CONSULTING GROUP, INC. 7361 CALHOUN PL.#500 Rockville, MD 20855 -2774
• Contact: Eduardo March
• Correspondent: Eduardo March; AAC CONSULTING GROUP, INC. 7361 CALHOUN PL.#500 Rockville, MD 20855 -2774
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-08
• Decision Date: 2002-10-25
• Summary: summary