ANU ICE

Device, Thermal, Hemorrhoids

CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC.

The following data is part of a premarket notification filed by Cryoptherapy Pain Relief Products, Inc. with the FDA for Anu Ice.

Pre-market Notification Details

Device IDK981428
510k NumberK981428
Device Name:ANU ICE
ClassificationDevice, Thermal, Hemorrhoids
Applicant CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. 272 N.W.106 TERRACE Pembroke Pines,  FL  33026
ContactJorge Caballero
CorrespondentJorge Caballero
CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. 272 N.W.106 TERRACE Pembroke Pines,  FL  33026
Product CodeLKX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-20
Decision Date1998-07-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.