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 |