ISOLATE

Media, Reproductive

IRVINE SCIENTIFIC SALES CO., INC.

The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Isolate.

Pre-market Notification Details

• Device ID: K971809
• 510k Number: K971809
• Device Name: ISOLATE
• Classification: Media, Reproductive
• Applicant: IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705
• Contact: Ken Lydersen
• Correspondent: Ken Lydersen; IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-15
• Decision Date: 1997-07-03
• Summary: summary