COLD PACK

Pack, Hot Or Cold, Reusable

FRIENDMED PRODUCTS

The following data is part of a premarket notification filed by Friendmed Products with the FDA for Cold Pack.

Pre-market Notification Details

• Device ID: K923627
• 510k Number: K923627
• Device Name: COLD PACK
• Classification: Pack, Hot Or Cold, Reusable
• Applicant: FRIENDMED PRODUCTS 754 S. MAIN ST. ATHENS, PA 18810
• Contact: MARYANN FRIEND
• Correspondent: MARYANN FRIEND; FRIENDMED PRODUCTS 754 S. MAIN ST. ATHENS, PA 18810
• Product Code: IME
• CFR Regulation Number: 890.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-21
• Decision Date: 1993-04-14