The following data is part of a premarket notification filed by Cryoptherapy Pain Relief Products, Inc. with the FDA for Anu Ice.
Device ID | K981428 |
510k Number | K981428 |
Device Name: | ANU ICE |
Classification | Device, Thermal, Hemorrhoids |
Applicant | CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. 272 N.W.106 TERRACE Pembroke Pines, FL 33026 |
Contact | Jorge Caballero |
Correspondent | Jorge Caballero CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. 272 N.W.106 TERRACE Pembroke Pines, FL 33026 |
Product Code | LKX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-20 |
Decision Date | 1998-07-07 |
Summary: | summary |