GEBAUER'S INSTANT ICE

Refrigerant, Topical (vapocoolant)

GEBAUER CO.

The following data is part of a premarket notification filed by Gebauer Co. with the FDA for Gebauer's Instant Ice.

Pre-market Notification Details

• Device ID: K021726
• 510k Number: K021726
• Device Name: GEBAUER'S INSTANT ICE
• Classification: Refrigerant, Topical (vapocoolant)
• Applicant: GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104
• Contact: Suzanne B Wojcik
• Correspondent: Suzanne B Wojcik; GEBAUER CO. 9410 ST. CATHERINE AVE. Cleveland, OH 44104
• Product Code: MLY
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-24
• Decision Date: 2002-12-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20303860010016	K021726	000