LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

Media, Reproductive

INTL., INC.

The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Lifeglobal Total, Total For Fertilization, Total W/hepes, Htf Total, Htf Total W/hepes.

Pre-market Notification Details

• Device ID: K112083
• 510k Number: K112083
• Device Name: LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
• Classification: Media, Reproductive
• Applicant: INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437
• Contact: Michael D Cecchi
• Correspondent: Michael D Cecchi; INTL., INC. 393 SOUNDVIEW RD. Guilford, CT 06437
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2011-07-21
• Decision Date: 2012-05-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815965020686	K112083	000
00815965020679	K112083	000
00815965020662	K112083	000
00815965020655	K112083	000
00815965020648	K112083	000
00815965020631	K112083	000
00815965020624	K112083	000
00815965020617	K112083	000
00815965020600	K112083	000