Rachel's Remedy

Pack, Heat, Moist

Rachel's Remedies, LLC

The following data is part of a premarket notification filed by Rachel's Remedies, Llc with the FDA for Rachel's Remedy.

Pre-market Notification Details

• Device ID: K150139
• 510k Number: K150139
• Device Name: Rachel's Remedy
• Classification: Pack, Heat, Moist
• Applicant: Rachel's Remedies, LLC 542 Parkside Ave Buffalo, NY 14216
• Contact: Rachel E. Jackson
• Correspondent: Rachel E. Jackson; Rachel's Remedies, LLC 542 Parkside Ave Buffalo, NY 14216
• Product Code: IMA
• CFR Regulation Number: 890.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-22
• Decision Date: 2015-05-22
• Summary: summary