510(k) Report

Devices descending from K970399

4 later devices reach Kwik Kold Peri Cold Pack (Catalog Number TBD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072082Gumease Dental MouthpieceBiomedevice, Ltd.20070—
+1K973770Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp.19972—
+2K021843Eyefeel Ophthalmic WarmerBio-Lipid, Inc.20021—
+3K082087Eyefeel Ophthalmic WarmerBio-Lipid, Inc.20080—